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NIH HEAL Initiative Pain-Related Funding Opportunities

The NIH HEAL (Helping to End Addiction Long-term) Initiative is an interdisciplinary program aimed at advancing addiction and pain research in the United States. The HEAL initiative will bolster research across NIH to improve treatments for opioid misuse and addiction and enhance pain management. The initial plans for the HEAL Initiative include support of research to understand how chronic pain develops as well as develop a data sharing collaborative, new biomarkers for pain, and a clinical trials network for testing new pain therapies.

To learn more about the NIH HEAL Initiative, please visit the NIH HEAL Website.

The following pain-related announcements are listed for your convenience. The complete list of HEAL initiative funding opportunities can be found at the NIH HEAL Funding Announcements and Opportunities website.

RFA-TR-19-005  Biofabricated 3D Tissue Models of Nociception, Opioid Use Disorder and Overdose for Drug Screening (UH2/UH3 – Clinical Trial Not Allowed)

The purpose of this Funding Opportunity Announcement (FOA) is to support intramural-extramural collaborations to develop and implement the use of 3D biofabricated tissue models as novel drug screening platforms and advance pre-clinical discovery and development of non-addictive treatments for nociception, opioid use disorder (OUD) and/or overdose. In particular, support during the UH2 phase is for the application of 3D biofabrication technologies to develop novel multicellular tissue constructs for drug screening by using human iPSC-derived cells representing sensory/pain neurons, brain regions, and other tissues involved in nociception, addiction and/or overdose, including tissue models of the blood-brain barrier (BBB). Support during the UH3 is for implementation of drug screens using the 3D tissue models developed during the UH2 phase.

This FOA is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at:  

https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative     

RFA-AR-19-026 Back Pain Consortium (BACPAC) Research Program: Mechanistic Research Centers (U19) (Clinical Trial Optional)

This Funding Opportunity Announcement (FOA) invites research applications to plan and implement Interdisciplinary Mechanistic Research Centers (MRC) in Low Back Pain (LBP) with the NIH Back Pain Consortium (BACPAC) Research Program. BACPAC is a patient-centric research program focused on translational and clinical research for discovery of chronic low back pain (cLBP) mechanisms, and on identification and testing of new interventions targeted to individual patients. BACPAC will utilize novel analytics and technologies to extensively phenotype patients with low back pain (LBP), develop an integrated model of cLBP, produce new and improved diagnostic and treatment algorithms, and test new therapies in Phase 2 clinical trials. The MRCs will conduct translational and clinical research projects addressing critical gaps and opportunities in LBP with advanced analytics and approaches to improve understanding of disease and identify new targets for intervention. The MRCs will generate data for deep patient phenotyping and for the development of patient-based algorithms. The MRCs will conduct collaborative, adaptive design, multimodal therapy studies in cLBP with the aim of improving the use of therapies targeted to individual patients.  The MRCs will run in parallel and synergize with projects supported in the BACPAC Data Integration, Algorithm Development and Operations Management Center, Technology Research Sites and Phase 2 Clinical Trials.  BACPAC is part of the multi-pronged HEAL (Helping to End Addiction Long-term) Initiative, an aggressive effort to speed scientific solutions to stem the national opioid public health crisis. (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative). HEAL will build on extensive, well-established NIH research to address the opioid crisis and provide safer therapies for people with pain.

NOT-NS-19-014  Notice of Interest in Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Applications Directed at Enhanced Pain Management and Improved Treatments for Opioid Misuse and Addiction

The purpose of this Notice is to rescind NOT-NS-18-076 and to inform potential SBIR and STTR applicants about areas of special interest related to the NIH Helping End Addiction Long-term (HEAL) Initiative , an effort to speed scientific solutions to stem the national opioid public health crisis.

The NIH Institutes and Centers listed in this notice are interested in receiving applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NIH is interested in new screening tools and models focused specifically on pain and development of pain therapies.

The National Institute on Drug Abuse (NIDA) is specifically interested in receiving applications to develop new approaches for the prevention and treatment of opioid misuse, overdose and addiction that will help people with opioid use disorder (OUD) achieve and maintain a meaningful and sustained recovery.

RFA-NS-19-017 Translational Devices to Treat Pain (U44 Clinical Trial Optional)

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue translational activities and clinical trials to treat pain with innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that improve patient outcomes and decrease or eliminate the need to prescribe opioids. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical trial (e.g., Early Feasibility Study). The clinical trial is expected to provide information about the device function or final design that cannot be practically obtained through additional nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress.

This FOA will leverage Public-Private Partnership Programs (PPP) initiated under the NIH BRAIN Initiative, the Office of Strategic Coordination – The Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program, and the NIH HEAL Initiative. These programs include agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research.  In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without the need for significant additional non-clinical data. 

For more information see https://braininitiative.nih.gov/resources/brain_ppp/index.htmhttps://commonfund.nih.gov/sparc/newmarkets, and https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/public-private-partnership. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or any of the companion opportunities.

NOT-TR-18-031  Announcement of the NCATS ASPIRE Design Challenges to Develop Innovative and Catalytic Approaches Towards Solving the Opioid Crisis

The goal of the inaugural NCATS ASPIRE (A Specialized Platform for Innovative Research Exploration) Design Challenges is to develop innovative and catalytic approaches towards solving the opioid crisis through development of (1) novel chemistries; (2) data-mining and analysis tools and technologies; and (3) biological assays that will revolutionize discovery, development and pre-clinical testing of next generation, safer and non-addictive analgesics to treat pain, as well as new treatments for opioid use disorder (OUD) and overdose. The first phase of this prizing competition is implemented through a suite of concurrent companion design challenges that comprises a separate challenge for each of four areas: chemistry database, electronic laboratory knowledge portal for synthetic chemistry, algorithms, and biological assays; and an additional challenge for a combined solution for at least two challenge areas. At this stage, innovators are expected to submit designs, not final products or prototypes.

The NCATS ASPIRE Challenges are part of the of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at:  https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

RFA-NS-19-016 Translational Devices to Treat Pain (UG3/UH3 Clinical Trial Optional)

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and clinical trials to treat pain with innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that improve patient outcomes and decrease or eliminate the need to prescribe opioids. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical trial (e.g., Early Feasibility Study). The clinical trial is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress.

This FOA will leverage Public-Private Partnership Programs (PPP) initiated under the NIH BRAIN Initiative, the Office of Strategic Coordination – The Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program, and the HEAL Initiative. These programs include agreements (Memoranda of Understanding,  MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research.  In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without the need for significant additional non-clinical data. 

For more information see https://braininitiative.nih.gov/resources/brain_ppp/index.htmhttps://commonfund.nih.gov/sparc/newmarkets, and https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/public-private-partnership. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or the companion opportunities.

RFA-NS-19-025 Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Specialized Clinical Centers (“hubs”) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs.

EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (“hubs”). The purpose of this funding opportunity announcement (FOA) is to invite applications for the hubs within EPPIC-Net. A hub will typically be a regional medical center that will actively enroll subjects into clinical trials and studies performed in EPPIC-Net. Each hub should have ready access to patient populations with specific pain conditions and have expertise in characterization of that pain condition. A hub will additionally provide scientific leadership and administrative oversight to its multiple (2-10) satellite sites (“spokes”).

This FOA solicits applications EPPIC-Net Specialized Clinical Centers. Separate FOAs have been issued to solicit applications for the Clinical Coordinating Center (RFA-NS-19-023) and Data Coordinating Center (RFA-NS-19-024). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL Partnership, as described above, or from separate NIH funding announcements.

RFA-TR-19-003 Tissue Chips to Model Nociception, Addiction, and Overdose (UG3/UH3 Clinical Trial Not Allowed)

This FOA will provide funding for Investigators to create and test devices that can model the mechanisms or effects of nociception/pain-relevant signaling, addiction, or opioid use disorders (OUDs), using human tissues in in vitro microphysiological systems (MPS).  Tissue chips, or microphysiological systems, are useful and promising in vitro human-based screening platforms because they closely mimic in vivo human physiology. Tissue chips have been shown to be capable of modeling normal and diseased physiology that faithfully recapitulates responses to stressors, treatments and other perturbations.

This FOA is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at:  https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

RFA-NS-19-024 Early Phase Pain Investigation Clinical Network - Data Coordinating Center (U24 Clinical Trials Not Allowed)

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Data Coordinating Center (DCC) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIH’s Helping to End Addiction Long-term (HEAL) Partnership. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in-depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs.

EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (“hubs”). As the main data manager for pain research in the HEAL Initiative, the EPPIC-Net DCC will host and manage clinical, neuroimaging, biomarker, omics, and preclinical data from EPPIC-Net and other components of the HEAL Initiative’s pain research program. The DCC will also make these data and clinical biosamples available to the research community to advance the science of pain. Lastly, the DCC will provide leadership in the statistical design and analysis of EPPIC-Net studies, and the systems and processes for data collection, management, quality assurance and reporting.

This FOA solicits applications for the EPPIC-Net Data Coordinating Center (DCC). Separate FOAs have been issued to solicit applications for the Clinical Coordinating Center (RFA-NS-19-023) and Specialized Clinical Centers (RFA-NS-19-025). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL initiative, as described above, or from separate NIH funding announcements.  

RFA-AT-19-005 Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required)

This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct an efficient, large-scale pragmatic trial to evaluate the impact of, and strategies to best implement, acupuncture treatment of older adults (65 years and older) with chronic low back pain.  This FOA requires that the intervention under study be embedded into health care delivery system, “real world” settings.  Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to an implementation phase (UH3). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the three-year UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA.

Trials must be conducted across two or more health care systems (HCS) and will become part of and work with the NIH HCS Research Collaboratory, which is supported through the NIH Common Fund (See https://commonfund.nih.gov/hcscollaboratory).  The NIH HCS Research Collaboratory Program has established a Collaboratory Coordinating Center (CCC) that is providing national leadership and technical expertise in all aspects of research with HCS. After awards are made by NIH, the CCC (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) and the NIH will work with awardees from this FOA to facilitate the planning and rapid execution of high impact trials that conduct research studies with partnering health care delivery systems.

RFA-NS-19-023 Early Phase Pain Investigation Clinical Network - Clinical Coordinating Center (U24 Clinical Trial Required)

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Clinical Coordinating Center (CCC) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIH’s Helping to End Addiction Long-term (HEAL) Partnership. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in-depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs.

EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (Hubs). The CCC will both help design and facilitate the implementation of clinical trials and studies.

This FOA solicits applications for EPPIC-Net CCC. Separate FOAs have been issued to solicit applications for the Data Coordinating Center (RFA-NS-19-024) and Specialized Clinical Centers (RFA-NS-19-025). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL Partnership or from separate NIH funding announcements.

RFA-AT-19-004 Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) (UG3/UH3, Clinical Trial Optional)

This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct efficient, large-scale pragmatic or implementation trials to improve pain management and reduce the unnecessary use of opioid medications. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to an implementation phase (UH3) of up to 4 years duration (5 years total for the two phases). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA.

The overall goal of this initiative is to support the "real world" assessment of health care strategies and clinical practices and procedures in health care systems that may lead to improved pain management along with a reduction in unnecessary opioid prescribing. This FOA requires that the intervention under study be embedded into health care delivery system, “real world” settings.  Studies can propose to integrate interventions that have demonstrated efficacy into health care systems; or implement health care system changes to improve adherence to evidence-based guidelines. Trials should be conducted across three or more health care systems (HCS) and will become part of and work with the NIH HCS Research Collaboratory supported through the NIH Common Fund. (See https://commonfund.nih.gov/hcscollaboratory).  The NIH HCS Research Collaboratory Program has established a Collaboratory Coordinating Center (CCC) that is providing national leadership and technical expertise in all aspects of research with HCS. Awarded applicants will work with the HCS CCC (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) to facilitate further planning and refinement of the proposed study in partnerships with health care delivery systems.

RFA-DK-18-031 Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Scientific and Data Research Center (U01 Clinical Trial Required)

Pain is a common problem in Medicare End-Stage Renal Disease (ESRD) Hemodialysis (HD) patients, but its prevalence varies widely by geography, dialysis unit, and possibly, ethnicity. Perception of pain has been linked to decreased quality of life, lack of social support, depressed mood and other mental health disorders. Chronic opioid prescription has been identified in approximately 20% of US ESRD HD patients, far higher than the rate in Medicare comparison populations. Opioid doses prescribed to HD patients exceed Centers for Disease Control and Prevention (CDC) recommendations. Prescription and dose level have been associated with increased hospitalizations and mortality in this population.

Interventions including behavioral modification techniques — such as Cognitive Behavioral/Group Therapy – and social media platforms for sharing information and enhancing social support have not been employed to reduce the rate of opioid prescription and opioid use,  as well as addressing comorbid related issues such as depression, anxiety and pain in the HD population.  Medical interventions such as use of naloxone and buprenorphine have not been evaluated by randomized controlled trials in HD patients who use opioids. The ESRD HD population, because of its continuous longitudinal participation in monitored treatment and the availability of data resources is an ideal population in which to launch and monitor interventions.

The Hemodialysis Opioid Prescription Effort (HOPE) Consortium, composed of a Scientific and Data Research Center (SDRC) and 5 to 7 Clinical Centers (CCs) will develop an intervention to simultaneously address the problem of pain and opioid use in US HD populations a) by initiating multipronged pain treatment tailored individually to each patient, without opioids, and b) by using buprenorphine and other novel agents to reduce dependence on opioids in affected patients. Multipronged interventions can include behavioral modification techniques—such as Cognitive Behavioral/Group Therapy, which can be designed according to each participants’ psychosocial profile, as well as alternative therapies, such as acupuncture — and can use social media platforms for implementation and evaluation. Analyses will consider comorbid illnesses (such as diabetes mellitus and  mental health disorders) and social determinants of health (such as socioeconomic status, social isolation, social support, residential factors and perception of racial discrimination) to identify novel risk factors for pain and opioid use in this population. End points will be chronic opioid prescription rate, prescription drug dose, pain control, patient satisfaction with care, perception of quality of life, hospitalization rates and mortality. Real time risk factor and outcome data may be captured using the electronic health record (EHR), by leveraging and expanding an existing pilot set of more than 200 standardized data elements identified and prioritized for comprehensive chronic kidney disease (CKD) care by the NIDDK CKD eCare Plan Working Group.

RFA-DK-18-030 Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Clinical Centers (U01 Clinical Trial Required)

Pain is a common problem in Medicare End-Stage Renal Disease (ESRD) Hemodialysis (HD) patients, but its prevalence varies widely by geography, dialysis unit, and possibly, ethnicity. Pain has been linked to decreased quality of life, lack of social support, depressed mood and other mental health disorders. Chronic opioid prescription has been identified in approximately 20% of US ESRD HD patients, far higher than in Medicare comparison populations. Opioid doses prescribed to HD patients exceed Centers for Disease Control and Prevention (CDC) recommendations. Prescription and dose level have been associated with increased hospitalizations and mortality in this population.

Interventions including behavioral modification techniques — such as Cognitive Behavioral/Group Therapy – and social media platforms for sharing information and enhancing social support have not been employed to reduce perception of pain and the rate of opioid prescription, dose and  opioid use,  as well as addressing comorbid related issues such as depression, and anxiety in the HD population.   Medical interventions such as use of naloxone and buprenorphine have not been evaluated by randomized controlled trials in HD patients who use opioids. The ESRD population, because of its continuous longitudinal participation in monitored treatment and the availability of data resources is an ideal population in which to launch and monitor interventions.

The Hemodialysis Opioid Prescription Effort (HOPE) consortium composed of 5 to 7 Clinical Centers (CCs) and a Scientific and Data Research Center (SDRC) will develop an intervention to simultaneously address the problem of pain and opioid use in US HD populations by a) initiating multipronged pain treatment tailored individually to each patient, without opioids, and b) using buprenorphine and other novel agents to reduce dependence on opioids in affected patients. Multipronged interventions can include behavioral modification techniques—such as Cognitive Behavioral/Group Therapy, which can be designed according to each participants’ psychosocial profile, as well as alternative therapies, such as acupuncture — and can use social media platforms for implementation and evaluation. Analyses will consider comorbid illnesses (such as diabetes and mental health disorders) and social determinants of health (such as socioeconomic status, social isolation, social support, residential factors, and perception of racial discrimination) to identify novel risk factors for pain and opioid use in this population. End points will be chronic opioid prescription rate, prescription drug dose, pain control, patient satisfaction with care, perception of quality of life, hospitalization rates and mortality. Real time risk factor and outcomes data may be captured using the electronic health record (EHR), by leveraging and expanding an existing pilot set of more than 200 standardized data elements identified and prioritized for comprehensive CKD care by the NIDDK CKD eCare Plan Working Group.

RFA-AR-19-029 Back Pain Consortium (BACPAC) Research Program: Phase 2 Clinical Trials (UG3/UH3) (Clinical Trial Required)

This Funding Opportunity Announcement (FOA) invites research applications to plan and implement Phase 2 clinical trials (Phase 2CT) in chronic Low Back Pain (cLBP) with the NIH Back Pain Consortium (BACPAC) Research Program.  BACPAC will carry out a patient centric-research program focused on translational and clinical research for discovery of chronic low back pain mechanisms, and on identification and testing of new interventions targeted to individual patients. BACPAC will utilize novel analytics and technologies to extensively phenotype patients with low back pain, develop an integrated model of cLBP and produce new and improved diagnostic and treatment algorithms.  BACPAC Phase 2 clinical trials (Phase 2CT) will evaluate interventions including medications, biologics, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, rehabilitation strategies, complementary therapies for cLBP. The studies will use randomized trial design as well as adaptive, phase 2/proof of concept design studies in stratified patient populations. Clinical trials may be conducted within the infrastructure of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) (formerly known as the Clinical Trial Network for Pain Research CTNPR). The Phase 2CTs will run in parallel and will synergize with projects supported in the BACPAC Mechanistic Research Centers, the Data Integration, Algorithm Development and Operations Management Center and the Technology Research Sites. 

RFA-AR-19-028 Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3) (Clinical Trial Optional)

This funding opportunity announcement (FOA) invites applications for the Technology Research Site component of the NIH Back Pain Consortium (BACPAC) Research Program. BACPAC is a patient centric-research program that will focus on translational and clinical research for discovery of chronic low back pain (cLBP) mechanisms, and on identification and testing of new interventions targeted to the individual patient. The Research Program will utilize novel analytics and technologies to extensively phenotype patients with low back pain, develop an integrated model of cLBP, produce new and improved diagnostic and treatment algorithms, and will conduct traditional Phase 2 Clinical Trials as well as sequential, adaptive, phase 2/proof of concept clinical studies in stratified patient populations.

The Technology Research Sites (Tech Sites) will develop, test and deploy novel analytic tools, technologies and/or methods (TTM) that will improve our understanding of mechanisms of cLBP. Collectively, they will contribute to the development of an integrated model of cLBP. The technology research and development will run in parallel and will synergize with projects supported in the BACPAC Mechanistic Research Centers, the Data Integration, Algorithm Development and Operations Management Center and the Phase 2 Clinical trials. Successful analytic TTM will be utilized clinically in BACPAC Phase 2 Clinical Trials and in multimodal, sequential, adaptive clinical studies in stratified patient populations. Where applicable, TTM developed by the Tech Sites will improve the diagnosis, treatment and prevention of recurrences of cLBP and/or be useful for defining different mechanisms in different patients and contribute to the development of algorithms for individualized treatment plans.

RFA-AR-19-027 Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center (U24) (Clinical Trial Not Allowed)

This funding opportunity announcement (FOA) invites applications for the NIH Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center.  BACPAC is a patient centric-research program that will focus on translational and clinical research for discovery of chronic low back pain (cLBP) mechanisms, and on identification and testing of new interventions targeted to individual patient. The Research Program will utilize novel analytics and technologies to extensively phenotype patients with low back pain, develop an integrated model of cLBP, produce new and improved diagnostic and treatment algorithms, and will conduct traditional Phase 2 Clinical Trials as well as sequential, adaptive, phase 2/proof of concept clinical studies in stratified patient populations. 

BACPAC will include multiple Mechanistic Research Centers, Technology Research Sites, Phase 2 Clinical Trials (Phase 2CT) and a Data Integration, Algorithm Development and Operations Management Center (DAC). This FOA invites applications for the BACPAC Data Integration, Algorithm Development and Operations Management Center (U24) and runs in parallel with companion FOAs (RFA-AR-19-026) that invites applications for the BACPAC Mechanistic Research Centers, (RFA-AR-19-028) for the BACPAC Technology Sites, and (RFA-AR-19-029) for the Phase 2 Clinical Trials.

RFA-EB-18-003 Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)

The purpose of this Funding Opportunity Announcement (FOA) is to support preclinical development and demonstration of safe, effective, and non-addictive device-based technologies and approaches to treat pain. The goal of the program is to demonstrate treatment using credible neural targets for device-based interventions and/or diagnostics for pain, building upon the latest mechanistic knowledge about the anatomy and physiology of central, spinal, and peripheral pathways involved in pain. Awarded activities will facilitate the translation of new devices up to the stage of readiness for first in human (FIH) clinical trials by overcoming key challenges identified during preliminary proof-of-concept studies. The scope of the program includes technology development and optimization, and studies to prepare for approvals for human use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress.     

RFA-RM-19-001 Stimulating Peripheral Activity to Relieve Conditions (SPARC): Anatomical and Functional Mapping of Pain-Related Visceral Organ Neural Circuitry (U01 Clinical Optional)

The purpose of this NIH Funding Opportunity Announcement (FOA) is to invite research applications proposing to map neural circuitry mediating visceral organ pain. This FOA is part of the Stimulating Peripheral Activity to Relieve Conditions (SPARC) Common Fund program and is coordinated with the Translational Devices to Treat Pain (TDTP) initiatives of the NIH HEAL program (see Companion Funding Opportunities above). Detailed mapping of pain-mediating circuitry originating from visceral organ afferents will leverage the SPARC program to produce maps that could accelerate the development of non-addictive approaches to treat pain.

RFA-NS-19-020 Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain - (U44 Clinical Trial Not Allowed)

The purpose of this funding opportunity announcement (FOA) is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads towards clinical trials. Applicants must have a promising hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of this program includes optimization and early development activities, IND-enabling studies, and assembly of Investigational New Drug (IND) application. This is a milestone-driven phased cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress.

RFA-NS-19-018 Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat pain with innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that improve patient outcomes and decrease or eliminate the need to prescribe opioids. Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants.  The clinical trial should provide data to answer key questions about the function or final design of a device and is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress.

This FOA will leverage Public-Private Partnership Programs (PPP) initiated under the NIH BRAIN Initiative, the Office of Strategic Coordination – The Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program, and the HEAL Initiative. These programs include agreements (Memoranda of Understanding,  MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research.  In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without the need for significant additional non-clinical data. 

For more information see https://braininitiative.nih.gov/resources/brain_ppp/index.htmhttps://commonfund.nih.gov/sparc/newmarkets, and https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/public-private-partnership. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or any of the companion opportunities.

RFA-NS-19-010  Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)

The purpose of this funding opportunity announcement (FOA) is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads towards clinical trials. Applicants must have a promising hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of this program includes optimization and early development activities, IND-enabling studies, and assembly of Investigational New Drug (IND) application. This is a milestone-driven phased cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress.

RFA-NS-18-046 Analytical and/or Clinical Validation of a Candidate Biomarker for Pain (R61/R33 Clinical Trial Optional)

The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the validation of strong candidate biomarkers and endpoints for pain that can be used to facilitate the development of non-opioid pain therapeutics from discovery through Phase II clinical trials.  Specifically, the focus of this FOA is on advanced analytical and clinical validation of pain biomarkers, biomarker signatures, and/or endpoints using retrospective and/or prospective methods. It is assumed that: 1) a candidate biomarker has already been identified, 2) assay technology has already been developed, and 3) a working hypothesis regarding Context of Use is in place. Research supported by this FOA will ultimately demonstrate that biomarker or endpoint change is reliably correlated with variables such as clinical outcome, pathophysiologic subsets of pain, therapeutic target engagement or response to a pain therapeutic; in addition, biomarker response will demonstrate specificity to the pain condition or therapeutic as demonstrated at multiple clinical sites. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers, biomarker signatures and endpoints of pain to application in clinical trials (Phase II clinical trials and beyond) and in the spectrum of clinical practice. 

RFA-NS-18-043 Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed) 

The purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery and validation of novel therapeutic targets to facilitate the development of pain therapeutics.  Specifically, the focus of this FOA is on the basic science discovery of targets in the peripheral nervous system, central nervous system, immune system or other tissues in the body that can be used to develop treatments that have minimal side effects and little to no abuse/addiction liability. Research supported by this FOA must include rigorous validation studies to demonstrate the robustness of the target as a pain treatment target. This will lower the risk of adopting the target in translational projects to develop small molecules, biologics, natural substances, or devices that interact with this target for new pain treatments. Translational research to develop new medical devices is not the focus of this FOA. Basic science studies of pain and related systems in the body are responsive to this FOA and are encouraged in the context of novel pain therapeutic target discovery.

 

This FOA is not specific for any one or group of pain conditions. Projects to identify novel targets for acute pain, chronic pain, migraine, other headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, sickle-cell pain, post stroke pain, orofacial pain, etc. will be considered. Projects to identify novel targets for a combination of chronic overlapping pain conditions or for specific pathological conditions will be considered. Projects that seek to identify novel targets in specific populations such as women, children, older adults or other underrepresented groups will also be responsive to this FOA.

RFA-NS-18-042 Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R21 Clinical Trial Not Allowed)

This R21 NIH Exploratory/Developmental Grant supports exploratory and developmental research projects by providing support for the early and conceptual stages of pain target discovery and validation projects. These studies may involve considerable risk but may lead to a breakthrough in a pain treatment.

RFA-RM-18-032 The purpose of this FOA is to support the establishment of center(s) that will use cutting edge technologies to perform omics analyses (e.g. metabolomic, lipidomic, proteomic, extracellular RNA) of body fluids collected by the Acute to Chronic Pain Signatures (A2CPS) consortium. The omics data generated, in concert with other patient assessments, will be used to identify biosignatures predictive of susceptibility or resilience to the development of chronic pain.

RFA-RM-18-033 The purpose of this FOA is to support one Multisite Clinical Center (MCC) to implement the enrollment and multimodal longitudinal assessment of a large cohort of patients with acute pain from a musculoskeletal trauma to identify biosignatures for resilience to and/or the transition from acute to chronic pain.

RFA-RM-18-034 The purpose of this FOA is to support a Multisite Clinical Center to implement the enrollment and multimodal longitudinal assessment of a large cohort of acute peri-operative pain patients to identify a biosignature for resilience to and the transition from acute to chronic pain.

RFA-RM-18-035 The purpose of this FOA is to identify and support a Clinical Coordination Center (CCC) for the Common Fund Acute to Chronic Pain Signatures (A2CPS) Program. The Clinical Coordinating Center is expected to serve as the hub for the Multisite Clinical Centers (below) to support study design, efficiency, progress, and quality, and to coordinate and monitor study implementation across the clinical sites. The Clinical Coordinating Center will lead the consortium in developing and implementing standardized protocols, safety standards, staff training protocols, electronic health record (EHR) data standards, patient phenotyping and testing, and regulatory processes.

NOT-NS-18-073 This Notice is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis.

The validation of a biological target for the treatment of pain, i.e. the proof of its suitability for treating a specific or group of pain disorders, is critical to the development of new nonaddictive therapeutics. Therefore, NINDS and other participating Institutes and Centers (ICs) are inviting investigators to submit administrative supplements to PA-18-591 to expand existing ongoing pain target discovery research to add rigorous multimethod validation studies, and ultimately provide the validation of the pain therapeutic target necessary to accelerate the development of non-addictive treatments. 

Related Announcements

PA-18-591

RFA-NS-18-041 The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery of strong candidate biomarkers and endpoints for pain that can be used to facilitate the development of non-opioid pain therapeutics from discovery through Phase II clinical trials.  Specifically, the focus of this FOA is on the identification and initial biological, analytical and clinical validation of pain biomarkers, biomarker signatures, and/or endpoints. Although research supported by this FOA can include animal studies, it must also include preliminary human validation using carefully standardized human samples or human clinical studies. The goal of this initiative is to deliver candidate biomarkers, biomarker signatures, and/or endpoints that are ready for advanced clinical and analytical validation research.            

NOT-NS-18-074  The NINDS, with other NIH Institutes and Centers participating in the HEAL (Helping to End Addiction Long-term) Initiative, intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for research on the analytical and clinical validation of biomarkers, biomarker signatures, and endpoints for pain indications. The goal of this FOA will be to support the analytical and clinical validation of candidate biomarkers for use in the discovery and development of non-opiate alternatives to the treatment of pain conditions using retrospective and/or prospective methods. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) assay technology has already been developed, and 3) a working hypothesis regarding context of use is in place.

NOT-NS-18-076 The purpose of this Notice is to inform potential SBIR and STTR applicants about areas of special interest related to the NIH Helping End Addiction Long-term (HEAL) Initiative, an effort to speed scientific solutions to stem the national opioid public health crisis. The National Institute of Neurological Disorders and Stroke (NINDS) is interested in receiving applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NINDS is interested in new screening tools and models focused specifically on pain and development of pain therapies. The National Institute on Drug Abuse (NIDA) is specifically interested in receiving applications to develop new approaches for the prevention and treatment of opioid misuse, overdose and addiction that will help people with opioid use disorder (OUD) achieve and maintain a meaningful and sustained recovery.

Related Announcements

PA-18-573

PA-18-574

PA-18-575

PA-18-576

PAR-18-617

PAR-18-618

NOT-NS-18-069 The National Institute for Neurological Disorders and Stroke intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a Clinical Trials Network on Pain Research (CTNPR). The network will be charged with executing trials of high impact for the treatment of patients with acute and chronic pain. The CTNPR is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative.

The network will be composed of a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and ten Regional Clinical Centers together with their linked clinical sites.

The purpose of this notice is to allow potential applicants sufficient time to develop meaningful collaborations and projects for the clinical centers ("Hubs") CTNPR.  The CTNPR will enable exploratory clinical trials of investigational drugs and biologics, investigational devices, natural products, and surgical procedures for the treatment of pain.  These trials may validate biomarkers, provide proof of mechanism, and otherwise contribute to the justification for proceeding or not proceeding to a future Phase 3 trial (e.g., informing go/n-go decisions).  The specific pain conditions will include well-defined ones with high unmet needs and more common, chronic neuropathic, inflammatory or nociceptive pain disorders in adult and pediatric populations. The network will focus on multi-site Phase 2 trials.  The network will also implement clinical studies for biomarker discovery and validation, and will store biomarker data and samples for future biomarker discovery.  It is anticipated that the CTNPR will be able to run as many as five Phase 2 trials concurrently in addition to biomarker validation studies.

NOT-NS-18-057 The National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a Data Coordinating Center (DCC) for a new Clinical Trials Network on Pain Research (CTNPR). This CTNPR is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative.

The CTNPR will enable exploratory clinical trials of investigational drugs and biologics, investigational devices, natural products, and surgical procedures for the treatment of pain.  These trials may validate biomarkers, provide proof of mechanism, and otherwise contribute to the justification for and provide the data required for designing a future Phase 3 trial.  The specific pain conditions will include well-defined ones with high unmet needs and more common, chronic neuropathic, inflammatory or nociceptive pain disorders in adult and pediatric populations. The network will also implement clinical studies for biomarker discovery and validation, and will store biomarker data and samples for future biomarker discovery.  It is anticipated that the CTNPR will be able to run as many as five Phase 2 trials concurrently in addition to biomarker validation studies. Further, it is anticipated that a number of the investigational drugs, biologics, and devices tested may come from private companies or academics.   

The DCC will have responsibility for web-based data collection, data management and quality assurance, statistical design and analysis, and reporting to the Data and Safety Monitoring Boards and regulatory and oversight groups.  More importantly, the DCC will be expected to provide innovative statistical leadership to the CTNPR with the goal of accelerating the discovery and evaluation of treatments for pain. The DCC will also house a data repository and biosample repository. It is envisioned that the DCC will also serve as the convener of an Expert Panel that consists of objective subject matter experts with experience in developing therapeutics. This Expert Panel would serve as the liaison to private companies who may contribute therapeutics to the CTNPR for testing. These analyses will be submitted to an NIH Scientific Review committee for prioritization.

NOT-NS-18-058 The National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a Clinical Coordinating Center (CCC) for a new Clinical Trials Network on Pain Research (CTNPR).  The CTNPR is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative.

The network will be charged with testing novel, non-addictive treatments for patients suffering from acute or chronic pain conditions.

The CTNPR will harness multidisciplinary expertise in pain science and clinical research to collaboratively design and conduct Phase 2 multicenter clinical trials testing novel pain treatments. It will also perform validation studies of biomarkers with promise to inform target engagement or proof of principle in Phase 2 clinical trials.  The CTNPR will develop deeply phenotyped cohorts with specific acute and chronic pain conditions in adults and children. The emphasis of the CTNPR will be on pain conditions of high unmet needs.

Interventions to be studied may include drugs, biologics, devices, natural products and surgical procedures.  The CTNPR will be composed of one CCC, one Data Coordinating Center (DCC), and approximately 10 clinical centers (Hubs).  The Hubs will be Centers of Excellence with physicians with pain expertise from neurology, anesthesiology, rheumatology, physical medicine, obstetrics/gynecology, pediatrics, orthopedics, gastroenterology, and other subspecialties providing care to patients with pain.  Each Hub is envisioned as a regional medical center that will enroll patients along with its network of 2-10 satellite sites (Spokes).   

NOT-NS-18-080  The NINDS, with other NIH Institutes and Centers participating in the HEAL (Helping to End Addiction Long-term) Initiative, intends to publish a Funding Opportunity Announcement (FOA) to solicit applications to discover and validate novel nonaddictive pain targets.

The focus of this FOA will be on the basic science discovery of targets in the peripheral nervous system, central nervous system, immune system or other tissues in the body that can be used to develop pain therapeutics that have minimal side effects and little to no abuse/addiction liability. Research that will be supported by this FOA must include rigorous validation studies to demonstrate the robustness of the target as a pain treatment target.  These studies should have the goal of definitively determining the utility of a potential target for future therapeutic and/or device development.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

This FOA is expected to be published in October 2018 with an expected application due date in November 2018.

NIH Funding Opportunities focused primarily on pain

RFA-AR-19-026 Back Pain Consortium (BACPAC) Research Program: Mechanistic Research Centers (U19) (Clinical Trial Optional)

This Funding Opportunity Announcement (FOA) invites research applications to plan and implement Interdisciplinary Mechanistic Research Centers (MRC) in Low Back Pain (LBP) with the NIH Back Pain Consortium (BACPAC) Research Program. BACPAC is a patient-centric research program focused on translational and clinical research for discovery of chronic low back pain (cLBP) mechanisms, and on identification and testing of new interventions targeted to individual patients. BACPAC will utilize novel analytics and technologies to extensively phenotype patients with low back pain (LBP), develop an integrated model of cLBP, produce new and improved diagnostic and treatment algorithms, and test new therapies in Phase 2 clinical trials. The MRCs will conduct translational and clinical research projects addressing critical gaps and opportunities in LBP with advanced analytics and approaches to improve understanding of disease and identify new targets for intervention. The MRCs will generate data for deep patient phenotyping and for the development of patient-based algorithms. The MRCs will conduct collaborative, adaptive design, multimodal therapy studies in cLBP with the aim of improving the use of therapies targeted to individual patients.  The MRCs will run in parallel and synergize with projects supported in the BACPAC Data Integration, Algorithm Development and Operations Management Center, Technology Research Sites and Phase 2 Clinical Trials.  BACPAC is part of the multi-pronged HEAL (Helping to End Addiction Long-term) Initiative, an aggressive effort to speed scientific solutions to stem the national opioid public health crisis. (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative). HEAL will build on extensive, well-established NIH research to address the opioid crisis and provide safer therapies for people with pain.

RFA-NS-19-021 Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

The purpose of this Funding Opportunity Announcement (FOA) is to solicit cooperative agreement applications that propose clinical trials to test the comparative effectiveness of existing therapies or effectiveness of existing or novel approaches for prevention and management of pain while reducing risk of addiction. The studies must address questions within the mission and research interests of participating NIH Institutes and Centers and evaluate preventive strategies or interventions including medications, biologics, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, rehabilitation strategies, complementary therapies, integrated approaches, and delivery system strategies in well controlled trials in specific pain conditions. The overall goal is to inform clinicians about the effectiveness of interventions or management strategies that reduce opioid use that will improve functional outcomes and reduce pain across the continuum of acute to chronic pain associated with many types of diseases or conditions or pain presenting as a disease itself. Clinical trials will be conducted within the infrastructure of the HEAL Pain Effectiveness Research Network.

RFA-TR-19-005  Biofabricated 3D Tissue Models of Nociception, Opioid Use Disorder and Overdose for Drug Screening (UH2/UH3 – Clinical Trial Not Allowed)

The purpose of this Funding Opportunity Announcement (FOA) is to support intramural-extramural collaborations to develop and implement the use of 3D biofabricated tissue models as novel drug screening platforms and advance pre-clinical discovery and development of non-addictive treatments for nociception, opioid use disorder (OUD) and/or overdose. In particular, support during the UH2 phase is for the application of 3D biofabrication technologies to develop novel multicellular tissue constructs for drug screening by using human iPSC-derived cells representing sensory/pain neurons, brain regions, and other tissues involved in nociception, addiction and/or overdose, including tissue models of the blood-brain barrier (BBB). Support during the UH3 is for implementation of drug screens using the 3D tissue models developed during the UH2 phase.

This FOA is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at:  

https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative     

RFA-AR-19-027 Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center (U24) (Clinical Trial Not Allowed)

This funding opportunity announcement (FOA) invites applications for the NIH Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center.  BACPAC is a patient centric-research program that will focus on translational and clinical research for discovery of chronic low back pain (cLBP) mechanisms, and on identification and testing of new interventions targeted to individual patient. The Research Program will utilize novel analytics and technologies to extensively phenotype patients with low back pain, develop an integrated model of cLBP, produce new and improved diagnostic and treatment algorithms, and will conduct traditional Phase 2 Clinical Trials as well as sequential, adaptive, phase 2/proof of concept clinical studies in stratified patient populations. 

BACPAC will include multiple Mechanistic Research Centers, Technology Research Sites, Phase 2 Clinical Trials (Phase 2CT) and a Data Integration, Algorithm Development and Operations Management Center (DAC). This FOA invites applications for the BACPAC Data Integration, Algorithm Development and Operations Management Center (U24) and runs in parallel with companion FOAs (RFA-AR-19-026) that invites applications for the BACPAC Mechanistic Research Centers, (RFA-AR-19-028) for the BACPAC Technology Sites, and (RFA-AR-19-029) for the Phase 2 Clinical Trials.

RFA-EB-18-003 Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)

The purpose of this Funding Opportunity Announcement (FOA) is to support preclinical development and demonstration of safe, effective, and non-addictive device-based technologies and approaches to treat pain. The goal of the program is to demonstrate treatment using credible neural targets for device-based interventions and/or diagnostics for pain, building upon the latest mechanistic knowledge about the anatomy and physiology of central, spinal, and peripheral pathways involved in pain. Awarded activities will facilitate the translation of new devices up to the stage of readiness for first in human (FIH) clinical trials by overcoming key challenges identified during preliminary proof-of-concept studies. The scope of the program includes technology development and optimization, and studies to prepare for approvals for human use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress.     

RFA-RM-19-001 Stimulating Peripheral Activity to Relieve Conditions (SPARC): Anatomical and Functional Mapping of Pain-Related Visceral Organ Neural Circuitry (U01 Clinical Optional)

The purpose of this NIH Funding Opportunity Announcement (FOA) is to invite research applications proposing to map neural circuitry mediating visceral organ pain. This FOA is part of the Stimulating Peripheral Activity to Relieve Conditions (SPARC) Common Fund program and is coordinated with the Translational Devices to Treat Pain (TDTP) initiatives of the NIH HEAL program (see Companion Funding Opportunities above). Detailed mapping of pain-mediating circuitry originating from visceral organ afferents will leverage the SPARC program to produce maps that could accelerate the development of non-addictive approaches to treat pain.

RFA-NS-19-020 Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain - (U44 Clinical Trial Not Allowed)

The purpose of this funding opportunity announcement (FOA) is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads towards clinical trials. Applicants must have a promising hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of this program includes optimization and early development activities, IND-enabling studies, and assembly of Investigational New Drug (IND) application. This is a milestone-driven phased cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress.

NOT-NS-19-014  Notice of Interest in Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Applications Directed at Enhanced Pain Management and Improved Treatments for Opioid Misuse and Addiction

The purpose of this Notice is to rescind NOT-NS-18-076 and to inform potential SBIR and STTR applicants about areas of special interest related to the NIH Helping End Addiction Long-term (HEAL) Initiative , an effort to speed scientific solutions to stem the national opioid public health crisis.

The NIH Institutes and Centers listed in this notice are interested in receiving applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NIH is interested in new screening tools and models focused specifically on pain and development of pain therapies.

The National Institute on Drug Abuse (NIDA) is specifically interested in receiving applications to develop new approaches for the prevention and treatment of opioid misuse, overdose and addiction that will help people with opioid use disorder (OUD) achieve and maintain a meaningful and sustained recovery.

RFA-NS-19-018 Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat pain with innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that improve patient outcomes and decrease or eliminate the need to prescribe opioids. Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants.  The clinical trial should provide data to answer key questions about the function or final design of a device and is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress.

This FOA will leverage Public-Private Partnership Programs (PPP) initiated under the NIH BRAIN Initiative, the Office of Strategic Coordination – The Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program, and the HEAL Initiative. These programs include agreements (Memoranda of Understanding,  MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research.  In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without the need for significant additional non-clinical data. 

For more information see https://braininitiative.nih.gov/resources/brain_ppp/index.htmhttps://commonfund.nih.gov/sparc/newmarkets, and https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/public-private-partnership. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or any of the companion opportunities.

NOT-TR-18-031  Announcement of the NCATS ASPIRE Design Challenges to Develop Innovative and Catalytic Approaches Towards Solving the Opioid Crisis

The goal of the inaugural NCATS ASPIRE (A Specialized Platform for Innovative Research Exploration) Design Challenges is to develop innovative and catalytic approaches towards solving the opioid crisis through development of (1) novel chemistries; (2) data-mining and analysis tools and technologies; and (3) biological assays that will revolutionize discovery, development and pre-clinical testing of next generation, safer and non-addictive analgesics to treat pain, as well as new treatments for opioid use disorder (OUD) and overdose. The first phase of this prizing competition is implemented through a suite of concurrent companion design challenges that comprises a separate challenge for each of four areas: chemistry database, electronic laboratory knowledge portal for synthetic chemistry, algorithms, and biological assays; and an additional challenge for a combined solution for at least two challenge areas. At this stage, innovators are expected to submit designs, not final products or prototypes.

The NCATS ASPIRE Challenges are part of the of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at:  https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

RFA-NS-19-017 Translational Devices to Treat Pain (U44 Clinical Trial Optional)

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue translational activities and clinical trials to treat pain with innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that improve patient outcomes and decrease or eliminate the need to prescribe opioids. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical trial (e.g., Early Feasibility Study). The clinical trial is expected to provide information about the device function or final design that cannot be practically obtained through additional nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress.

This FOA will leverage Public-Private Partnership Programs (PPP) initiated under the NIH BRAIN Initiative, the Office of Strategic Coordination – The Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program, and the NIH HEAL Initiative. These programs include agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research.  In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without the need for significant additional non-clinical data. 

For more information see https://braininitiative.nih.gov/resources/brain_ppp/index.htmhttps://commonfund.nih.gov/sparc/newmarkets, and https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/public-private-partnership. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or any of the companion opportunities.

RFA-NS-19-016 Translational Devices to Treat Pain (UG3/UH3 Clinical Trial Optional)

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and clinical trials to treat pain with innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that improve patient outcomes and decrease or eliminate the need to prescribe opioids. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical trial (e.g., Early Feasibility Study). The clinical trial is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress.

This FOA will leverage Public-Private Partnership Programs (PPP) initiated under the NIH BRAIN Initiative, the Office of Strategic Coordination – The Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program, and the HEAL Initiative. These programs include agreements (Memoranda of Understanding,  MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research.  In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without the need for significant additional non-clinical data. 

For more information see https://braininitiative.nih.gov/resources/brain_ppp/index.htmhttps://commonfund.nih.gov/sparc/newmarkets, and https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/public-private-partnership. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or the companion opportunities.

RFA-TR-19-003 Tissue Chips to Model Nociception, Addiction, and Overdose (UG3/UH3 Clinical Trial Not Allowed)

This FOA will provide funding for Investigators to create and test devices that can model the mechanisms or effects of nociception/pain-relevant signaling, addiction, or opioid use disorders (OUDs), using human tissues in in vitro microphysiological systems (MPS).  Tissue chips, or microphysiological systems, are useful and promising in vitro human-based screening platforms because they closely mimic in vivo human physiology. Tissue chips have been shown to be capable of modeling normal and diseased physiology that faithfully recapitulates responses to stressors, treatments and other perturbations.

This FOA is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at:  https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

RFA-NS-19-025 Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Specialized Clinical Centers (“hubs”) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs.

EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (“hubs”). The purpose of this funding opportunity announcement (FOA) is to invite applications for the hubs within EPPIC-Net. A hub will typically be a regional medical center that will actively enroll subjects into clinical trials and studies performed in EPPIC-Net. Each hub should have ready access to patient populations with specific pain conditions and have expertise in characterization of that pain condition. A hub will additionally provide scientific leadership and administrative oversight to its multiple (2-10) satellite sites (“spokes”).

This FOA solicits applications EPPIC-Net Specialized Clinical Centers. Separate FOAs have been issued to solicit applications for the Clinical Coordinating Center (RFA-NS-19-023) and Data Coordinating Center (RFA-NS-19-024). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL Partnership, as described above, or from separate NIH funding announcements.

RFA-AT-19-005 Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required)

This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct an efficient, large-scale pragmatic trial to evaluate the impact of, and strategies to best implement, acupuncture treatment of older adults (65 years and older) with chronic low back pain.  This FOA requires that the intervention under study be embedded into health care delivery system, “real world” settings.  Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to an implementation phase (UH3). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the three-year UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA.

Trials must be conducted across two or more health care systems (HCS) and will become part of and work with the NIH HCS Research Collaboratory, which is supported through the NIH Common Fund (See https://commonfund.nih.gov/hcscollaboratory).  The NIH HCS Research Collaboratory Program has established a Collaboratory Coordinating Center (CCC) that is providing national leadership and technical expertise in all aspects of research with HCS. After awards are made by NIH, the CCC (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) and the NIH will work with awardees from this FOA to facilitate the planning and rapid execution of high impact trials that conduct research studies with partnering health care delivery systems.

RFA-NS-19-024 Early Phase Pain Investigation Clinical Network - Data Coordinating Center (U24 Clinical Trials Not Allowed)

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Data Coordinating Center (DCC) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIH’s Helping to End Addiction Long-term (HEAL) Partnership. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in-depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs.

EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (“hubs”). As the main data manager for pain research in the HEAL Initiative, the EPPIC-Net DCC will host and manage clinical, neuroimaging, biomarker, omics, and preclinical data from EPPIC-Net and other components of the HEAL Initiative’s pain research program. The DCC will also make these data and clinical biosamples available to the research community to advance the science of pain. Lastly, the DCC will provide leadership in the statistical design and analysis of EPPIC-Net studies, and the systems and processes for data collection, management, quality assurance and reporting.

This FOA solicits applications for the EPPIC-Net Data Coordinating Center (DCC). Separate FOAs have been issued to solicit applications for the Clinical Coordinating Center (RFA-NS-19-023) and Specialized Clinical Centers (RFA-NS-19-025). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL initiative, as described above, or from separate NIH funding announcements.  

RFA-AT-19-004 Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) (UG3/UH3, Clinical Trial Optional)

This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct efficient, large-scale pragmatic or implementation trials to improve pain management and reduce the unnecessary use of opioid medications. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to an implementation phase (UH3) of up to 4 years duration (5 years total for the two phases). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA.

The overall goal of this initiative is to support the "real world" assessment of health care strategies and clinical practices and procedures in health care systems that may lead to improved pain management along with a reduction in unnecessary opioid prescribing. This FOA requires that the intervention under study be embedded into health care delivery system, “real world” settings.  Studies can propose to integrate interventions that have demonstrated efficacy into health care systems; or implement health care system changes to improve adherence to evidence-based guidelines. Trials should be conducted across three or more health care systems (HCS) and will become part of and work with the NIH HCS Research Collaboratory supported through the NIH Common Fund. (See https://commonfund.nih.gov/hcscollaboratory).  The NIH HCS Research Collaboratory Program has established a Collaboratory Coordinating Center (CCC) that is providing national leadership and technical expertise in all aspects of research with HCS. Awarded applicants will work with the HCS CCC (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) to facilitate further planning and refinement of the proposed study in partnerships with health care delivery systems.

RFA-NS-19-023 Early Phase Pain Investigation Clinical Network - Clinical Coordinating Center (U24 Clinical Trial Required)

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Clinical Coordinating Center (CCC) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIH’s Helping to End Addiction Long-term (HEAL) Partnership. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in-depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs.

EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (Hubs). The CCC will both help design and facilitate the implementation of clinical trials and studies.

This FOA solicits applications for EPPIC-Net CCC. Separate FOAs have been issued to solicit applications for the Data Coordinating Center (RFA-NS-19-024) and Specialized Clinical Centers (RFA-NS-19-025). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL Partnership or from separate NIH funding announcements.

RFA-DK-18-031 Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Scientific and Data Research Center (U01 Clinical Trial Required)

Pain is a common problem in Medicare End-Stage Renal Disease (ESRD) Hemodialysis (HD) patients, but its prevalence varies widely by geography, dialysis unit, and possibly, ethnicity. Perception of pain has been linked to decreased quality of life, lack of social support, depressed mood and other mental health disorders. Chronic opioid prescription has been identified in approximately 20% of US ESRD HD patients, far higher than the rate in Medicare comparison populations. Opioid doses prescribed to HD patients exceed Centers for Disease Control and Prevention (CDC) recommendations. Prescription and dose level have been associated with increased hospitalizations and mortality in this population.

Interventions including behavioral modification techniques — such as Cognitive Behavioral/Group Therapy – and social media platforms for sharing information and enhancing social support have not been employed to reduce the rate of opioid prescription and opioid use,  as well as addressing comorbid related issues such as depression, anxiety and pain in the HD population.  Medical interventions such as use of naloxone and buprenorphine have not been evaluated by randomized controlled trials in HD patients who use opioids. The ESRD HD population, because of its continuous longitudinal participation in monitored treatment and the availability of data resources is an ideal population in which to launch and monitor interventions.

The Hemodialysis Opioid Prescription Effort (HOPE) Consortium, composed of a Scientific and Data Research Center (SDRC) and 5 to 7 Clinical Centers (CCs) will develop an intervention to simultaneously address the problem of pain and opioid use in US HD populations a) by initiating multipronged pain treatment tailored individually to each patient, without opioids, and b) by using buprenorphine and other novel agents to reduce dependence on opioids in affected patients. Multipronged interventions can include behavioral modification techniques—such as Cognitive Behavioral/Group Therapy, which can be designed according to each participants’ psychosocial profile, as well as alternative therapies, such as acupuncture — and can use social media platforms for implementation and evaluation. Analyses will consider comorbid illnesses (such as diabetes mellitus and  mental health disorders) and social determinants of health (such as socioeconomic status, social isolation, social support, residential factors and perception of racial discrimination) to identify novel risk factors for pain and opioid use in this population. End points will be chronic opioid prescription rate, prescription drug dose, pain control, patient satisfaction with care, perception of quality of life, hospitalization rates and mortality. Real time risk factor and outcome data may be captured using the electronic health record (EHR), by leveraging and expanding an existing pilot set of more than 200 standardized data elements identified and prioritized for comprehensive chronic kidney disease (CKD) care by the NIDDK CKD eCare Plan Working Group.

RFA-DK-18-030 Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Clinical Centers (U01 Clinical Trial Required)

Pain is a common problem in Medicare End-Stage Renal Disease (ESRD) Hemodialysis (HD) patients, but its prevalence varies widely by geography, dialysis unit, and possibly, ethnicity. Pain has been linked to decreased quality of life, lack of social support, depressed mood and other mental health disorders. Chronic opioid prescription has been identified in approximately 20% of US ESRD HD patients, far higher than in Medicare comparison populations. Opioid doses prescribed to HD patients exceed Centers for Disease Control and Prevention (CDC) recommendations. Prescription and dose level have been associated with increased hospitalizations and mortality in this population.

Interventions including behavioral modification techniques — such as Cognitive Behavioral/Group Therapy – and social media platforms for sharing information and enhancing social support have not been employed to reduce perception of pain and the rate of opioid prescription, dose and  opioid use,  as well as addressing comorbid related issues such as depression, and anxiety in the HD population.   Medical interventions such as use of naloxone and buprenorphine have not been evaluated by randomized controlled trials in HD patients who use opioids. The ESRD population, because of its continuous longitudinal participation in monitored treatment and the availability of data resources is an ideal population in which to launch and monitor interventions.

The Hemodialysis Opioid Prescription Effort (HOPE) consortium composed of 5 to 7 Clinical Centers (CCs) and a Scientific and Data Research Center (SDRC) will develop an intervention to simultaneously address the problem of pain and opioid use in US HD populations by a) initiating multipronged pain treatment tailored individually to each patient, without opioids, and b) using buprenorphine and other novel agents to reduce dependence on opioids in affected patients. Multipronged interventions can include behavioral modification techniques—such as Cognitive Behavioral/Group Therapy, which can be designed according to each participants’ psychosocial profile, as well as alternative therapies, such as acupuncture — and can use social media platforms for implementation and evaluation. Analyses will consider comorbid illnesses (such as diabetes and mental health disorders) and social determinants of health (such as socioeconomic status, social isolation, social support, residential factors, and perception of racial discrimination) to identify novel risk factors for pain and opioid use in this population. End points will be chronic opioid prescription rate, prescription drug dose, pain control, patient satisfaction with care, perception of quality of life, hospitalization rates and mortality. Real time risk factor and outcomes data may be captured using the electronic health record (EHR), by leveraging and expanding an existing pilot set of more than 200 standardized data elements identified and prioritized for comprehensive CKD care by the NIDDK CKD eCare Plan Working Group.

RFA-AR-19-029 Back Pain Consortium (BACPAC) Research Program: Phase 2 Clinical Trials (UG3/UH3) (Clinical Trial Required)

This Funding Opportunity Announcement (FOA) invites research applications to plan and implement Phase 2 clinical trials (Phase 2CT) in chronic Low Back Pain (cLBP) with the NIH Back Pain Consortium (BACPAC) Research Program.  BACPAC will carry out a patient centric-research program focused on translational and clinical research for discovery of chronic low back pain mechanisms, and on identification and testing of new interventions targeted to individual patients. BACPAC will utilize novel analytics and technologies to extensively phenotype patients with low back pain, develop an integrated model of cLBP and produce new and improved diagnostic and treatment algorithms.  BACPAC Phase 2 clinical trials (Phase 2CT) will evaluate interventions including medications, biologics, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, rehabilitation strategies, complementary therapies for cLBP. The studies will use randomized trial design as well as adaptive, phase 2/proof of concept design studies in stratified patient populations. Clinical trials may be conducted within the infrastructure of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) (formerly known as the Clinical Trial Network for Pain Research CTNPR). The Phase 2CTs will run in parallel and will synergize with projects supported in the BACPAC Mechanistic Research Centers, the Data Integration, Algorithm Development and Operations Management Center and the Technology Research Sites. 

RFA-AR-19-028 Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3) (Clinical Trial Optional)

This funding opportunity announcement (FOA) invites applications for the Technology Research Site component of the NIH Back Pain Consortium (BACPAC) Research Program. BACPAC is a patient centric-research program that will focus on translational and clinical research for discovery of chronic low back pain (cLBP) mechanisms, and on identification and testing of new interventions targeted to the individual patient. The Research Program will utilize novel analytics and technologies to extensively phenotype patients with low back pain, develop an integrated model of cLBP, produce new and improved diagnostic and treatment algorithms, and will conduct traditional Phase 2 Clinical Trials as well as sequential, adaptive, phase 2/proof of concept clinical studies in stratified patient populations.

The Technology Research Sites (Tech Sites) will develop, test and deploy novel analytic tools, technologies and/or methods (TTM) that will improve our understanding of mechanisms of cLBP. Collectively, they will contribute to the development of an integrated model of cLBP. The technology research and development will run in parallel and will synergize with projects supported in the BACPAC Mechanistic Research Centers, the Data Integration, Algorithm Development and Operations Management Center and the Phase 2 Clinical trials. Successful analytic TTM will be utilized clinically in BACPAC Phase 2 Clinical Trials and in multimodal, sequential, adaptive clinical studies in stratified patient populations. Where applicable, TTM developed by the Tech Sites will improve the diagnosis, treatment and prevention of recurrences of cLBP and/or be useful for defining different mechanisms in different patients and contribute to the development of algorithms for individualized treatment plans.

RFA-NS-19-010  Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)

The purpose of this funding opportunity announcement (FOA) is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads towards clinical trials. Applicants must have a promising hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of this program includes optimization and early development activities, IND-enabling studies, and assembly of Investigational New Drug (IND) application. This is a milestone-driven phased cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress.

(PA-18-943)  Biobehavioral Basis of Chronic Pain (R21 Clinical Trial Optional)
National Institute of Nursing Research
National Center for Complementary and Integrative Health
National Cancer Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Office of Behavioral and Social Science Research
Application Receipt/Submission Date(s): Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. The first standard application due date for this FOA is February 16, 2019. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

(PA-18-944) Biobehavioral Basis of Chronic Pain (R01 Clinical Trial Optional)

National Institute of Nursing Research
National Center for Complementary and Integrative Health
National Cancer Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Office of Behavioral and Social Science Research
Application Receipt/Submission Date(s): Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. The first standard application due date for this FOA is February 5, 2019. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

(PA-18-945)  Applying a Biopsychosocial Perspective to Self-Management of Chronic Pain (R01 Clinical Trial Optional)

National Institute of Nursing Research
National Center for Complementary and Integrative Health
National Cancer Institute
Office of Behavioral and Social Science Research
Application Receipt/Submission Date(s): Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. The first standard application due date for this FOA is February 5, 2019. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

 

 

(PA-18-946)  Applying a Biopsychosocial Perspective to Self-Management of Chronic Pain (R21 Clinical Trial Optional)

National Institute of Nursing Research
National Center for Complementary and Integrative Health
National Cancer Institute
Office of Behavioral and Social Science Research
Application Receipt/Submission Date(s): Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. The first standard application due date for this FOA is February 16, 2019. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

RFA-NS-18-042 Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R21 Clinical Trial Not Allowed)

This R21 NIH Exploratory/Developmental Grant supports exploratory and developmental research projects by providing support for the early and conceptual stages of pain target discovery and validation projects. These studies may involve considerable risk but may lead to a breakthrough in a pain treatment.

RFA-NS-18-046 Analytical and/or Clinical Validation of a Candidate Biomarker for Pain (R61/R33 Clinical Trial Optional)

The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the validation of strong candidate biomarkers and endpoints for pain that can be used to facilitate the development of non-opioid pain therapeutics from discovery through Phase II clinical trials.  Specifically, the focus of this FOA is on advanced analytical and clinical validation of pain biomarkers, biomarker signatures, and/or endpoints using retrospective and/or prospective methods. It is assumed that: 1) a candidate biomarker has already been identified, 2) assay technology has already been developed, and 3) a working hypothesis regarding Context of Use is in place. Research supported by this FOA will ultimately demonstrate that biomarker or endpoint change is reliably correlated with variables such as clinical outcome, pathophysiologic subsets of pain, therapeutic target engagement or response to a pain therapeutic; in addition, biomarker response will demonstrate specificity to the pain condition or therapeutic as demonstrated at multiple clinical sites. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers, biomarker signatures and endpoints of pain to application in clinical trials (Phase II clinical trials and beyond) and in the spectrum of clinical practice. 

RFA-NS-18-043 Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed) 

The purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery and validation of novel therapeutic targets to facilitate the development of pain therapeutics.  Specifically, the focus of this FOA is on the basic science discovery of targets in the peripheral nervous system, central nervous system, immune system or other tissues in the body that can be used to develop treatments that have minimal side effects and little to no abuse/addiction liability. Research supported by this FOA must include rigorous validation studies to demonstrate the robustness of the target as a pain treatment target. This will lower the risk of adopting the target in translational projects to develop small molecules, biologics, natural substances, or devices that interact with this target for new pain treatments. Translational research to develop new medical devices is not the focus of this FOA. Basic science studies of pain and related systems in the body are responsive to this FOA and are encouraged in the context of novel pain therapeutic target discovery.

 

This FOA is not specific for any one or group of pain conditions. Projects to identify novel targets for acute pain, chronic pain, migraine, other headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, sickle-cell pain, post stroke pain, orofacial pain, etc. will be considered. Projects to identify novel targets for a combination of chronic overlapping pain conditions or for specific pathological conditions will be considered. Projects that seek to identify novel targets in specific populations such as women, children, older adults or other underrepresented groups will also be responsive to this FOA.

RFA-RM-18-033 The purpose of this FOA is to support one Multisite Clinical Center (MCC) to implement the enrollment and multimodal longitudinal assessment of a large cohort of patients with acute pain from a musculoskeletal trauma to identify biosignatures for resilience to and/or the transition from acute to chronic pain.

RFA-RM-18-034 The purpose of this FOA is to support a Multisite Clinical Center to implement the enrollment and multimodal longitudinal assessment of a large cohort of acute peri-operative pain patients to identify a biosignature for resilience to and the transition from acute to chronic pain.

RFA-RM-18-035 The purpose of this FOA is to identify and support a Clinical Coordination Center (CCC) for the Common Fund Acute to Chronic Pain Signatures (A2CPS) Program. The Clinical Coordinating Center is expected to serve as the hub for the Multisite Clinical Centers (below) to support study design, efficiency, progress, and quality, and to coordinate and monitor study implementation across the clinical sites. The Clinical Coordinating Center will lead the consortium in developing and implementing standardized protocols, safety standards, staff training protocols, electronic health record (EHR) data standards, patient phenotyping and testing, and regulatory processes.

RFA-NS-18-041 The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery of strong candidate biomarkers and endpoints for pain that can be used to facilitate the development of non-opioid pain therapeutics from discovery through Phase II clinical trials.  Specifically, the focus of this FOA is on the identification and initial biological, analytical and clinical validation of pain biomarkers, biomarker signatures, and/or endpoints. Although research supported by this FOA can include animal studies, it must also include preliminary human validation using carefully standardized human samples or human clinical studies. The goal of this initiative is to deliver candidate biomarkers, biomarker signatures, and/or endpoints that are ready for advanced clinical and analytical validation research.            

NOT-NS-18-074  The NINDS, with other NIH Institutes and Centers participating in the HEAL (Helping to End Addiction Long-term) Initiative, intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for research on the analytical and clinical validation of biomarkers, biomarker signatures, and endpoints for pain indications. The goal of this FOA will be to support the analytical and clinical validation of candidate biomarkers for use in the discovery and development of non-opiate alternatives to the treatment of pain conditions using retrospective and/or prospective methods. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) assay technology has already been developed, and 3) a working hypothesis regarding context of use is in place.

NOT-NS-18-076 The purpose of this Notice is to inform potential SBIR and STTR applicants about areas of special interest related to the NIH Helping End Addiction Long-term (HEAL) Initiative, an effort to speed scientific solutions to stem the national opioid public health crisis. The National Institute of Neurological Disorders and Stroke (NINDS) is interested in receiving applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NINDS is interested in new screening tools and models focused specifically on pain and development of pain therapies. The National Institute on Drug Abuse (NIDA) is specifically interested in receiving applications to develop new approaches for the prevention and treatment of opioid misuse, overdose and addiction that will help people with opioid use disorder (OUD) achieve and maintain a meaningful and sustained recovery.

Related Announcements

PA-18-573

PA-18-574

PA-18-575

PA-18-576

PAR-18-617

PAR-18-618

NOT-NS-18-069 The National Institute for Neurological Disorders and Stroke intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a Clinical Trials Network on Pain Research (CTNPR). The network will be charged with executing trials of high impact for the treatment of patients with acute and chronic pain. The CTNPR is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative.

The network will be composed of a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and ten Regional Clinical Centers together with their linked clinical sites.

The purpose of this notice is to allow potential applicants sufficient time to develop meaningful collaborations and projects for the clinical centers ("Hubs") CTNPR.  The CTNPR will enable exploratory clinical trials of investigational drugs and biologics, investigational devices, natural products, and surgical procedures for the treatment of pain.  These trials may validate biomarkers, provide proof of mechanism, and otherwise contribute to the justification for proceeding or not proceeding to a future Phase 3 trial (e.g., informing go/n-go decisions).  The specific pain conditions will include well-defined ones with high unmet needs and more common, chronic neuropathic, inflammatory or nociceptive pain disorders in adult and pediatric populations. The network will focus on multi-site Phase 2 trials.  The network will also implement clinical studies for biomarker discovery and validation, and will store biomarker data and samples for future biomarker discovery.  It is anticipated that the CTNPR will be able to run as many as five Phase 2 trials concurrently in addition to biomarker validation studies.

NOT-NS-18-057 The National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a Data Coordinating Center (DCC) for a new Clinical Trials Network on Pain Research (CTNPR). This CTNPR is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative.

The CTNPR will enable exploratory clinical trials of investigational drugs and biologics, investigational devices, natural products, and surgical procedures for the treatment of pain.  These trials may validate biomarkers, provide proof of mechanism, and otherwise contribute to the justification for and provide the data required for designing a future Phase 3 trial.  The specific pain conditions will include well-defined ones with high unmet needs and more common, chronic neuropathic, inflammatory or nociceptive pain disorders in adult and pediatric populations. The network will also implement clinical studies for biomarker discovery and validation, and will store biomarker data and samples for future biomarker discovery.  It is anticipated that the CTNPR will be able to run as many as five Phase 2 trials concurrently in addition to biomarker validation studies. Further, it is anticipated that a number of the investigational drugs, biologics, and devices tested may come from private companies or academics.   

The DCC will have responsibility for web-based data collection, data management and quality assurance, statistical design and analysis, and reporting to the Data and Safety Monitoring Boards and regulatory and oversight groups.  More importantly, the DCC will be expected to provide innovative statistical leadership to the CTNPR with the goal of accelerating the discovery and evaluation of treatments for pain. The DCC will also house a data repository and biosample repository. It is envisioned that the DCC will also serve as the convener of an Expert Panel that consists of objective subject matter experts with experience in developing therapeutics. This Expert Panel would serve as the liaison to private companies who may contribute therapeutics to the CTNPR for testing. These analyses will be submitted to an NIH Scientific Review committee for prioritization.

NOT-NS-18-058 The National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a Clinical Coordinating Center (CCC) for a new Clinical Trials Network on Pain Research (CTNPR).  The CTNPR is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative.

The network will be charged with testing novel, non-addictive treatments for patients suffering from acute or chronic pain conditions.

The CTNPR will harness multidisciplinary expertise in pain science and clinical research to collaboratively design and conduct Phase 2 multicenter clinical trials testing novel pain treatments. It will also perform validation studies of biomarkers with promise to inform target engagement or proof of principle in Phase 2 clinical trials.  The CTNPR will develop deeply phenotyped cohorts with specific acute and chronic pain conditions in adults and children. The emphasis of the CTNPR will be on pain conditions of high unmet needs.

Interventions to be studied may include drugs, biologics, devices, natural products and surgical procedures.  The CTNPR will be composed of one CCC, one Data Coordinating Center (DCC), and approximately 10 clinical centers (Hubs).  The Hubs will be Centers of Excellence with physicians with pain expertise from neurology, anesthesiology, rheumatology, physical medicine, obstetrics/gynecology, pediatrics, orthopedics, gastroenterology, and other subspecialties providing care to patients with pain.  Each Hub is envisioned as a regional medical center that will enroll patients along with its network of 2-10 satellite sites (Spokes).   

NOT-NS-18-080  The NINDS, with other NIH Institutes and Centers participating in the HEAL (Helping to End Addiction Long-term) Initiative, intends to publish a Funding Opportunity Announcement (FOA) to solicit applications to discover and validate novel nonaddictive pain targets.

The focus of this FOA will be on the basic science discovery of targets in the peripheral nervous system, central nervous system, immune system or other tissues in the body that can be used to develop pain therapeutics that have minimal side effects and little to no abuse/addiction liability. Research that will be supported by this FOA must include rigorous validation studies to demonstrate the robustness of the target as a pain treatment target.  These studies should have the goal of definitively determining the utility of a potential target for future therapeutic and/or device development.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

This FOA is expected to be published in October 2018 with an expected application due date in November 2018.

NOT-NS-18-052 Notice of NINDS BRG, BRP, Translational Neural Devices, BRAIN Initiative: Next Generation Invasive Devices Recording, Modulation in the Human Central Nervous System, and Smart & Connected Health Program Applications Directed at the Treatment of Pain

The purpose of this Notice is to inform potential applicants to the National Institute of Neurological Disorders and Stroke (NINDS) Bioengineering Research Grants (BRG), Bioengineering Research Partnerships (BRP), Translational Neural Devices, and BRAIN Initiative: Next Generation Invasive Devices Recording and Modulation in the Human Central Nervous System, and Smart and Connected Health Funding Opportunity Announcements about an area of special interest.  NINDS would like to accelerate the development of devices for the treatment of pain. Investigators are strongly encouraged to contact the appropriate Program Director prior to submitting an application. Applications may be submitted to: PAR-18-206 (BRG),  PAR-18-208 (BRP),  RFA-NS-18-011 (Translational Neural Devices),  RFA-NS-18-012 (Translational Neural Devices - SBIR),  RFA-NS-18-021 (BRAIN Initiative),  RFA-NS-18-022 (BRAIN Initiative),  RFA-NS-18-023 (BRAIN Initiative - SBIR),  and NSF-18-541 (Smart and Connected Health).  

PA-18-465 Developing the Therapeutic Potential of the Endocannabinoid System for Pain Treatment

The purpose of this NIH Pain Consortium-endorsed FOA is to support projects examining the therapeutic potential of cannabinoids and endocannabinoid system across a variety of pain conditions. Research supported under this FOA is wide-ranging. In general, the goal is to understand the role of cannabinoids in the management of chronic pain, in part, to help mitigate the high rate of use and abuse of opioids.

PA-18-141, PA-18-159 Mechanisms, Models, Measurement, & Management in Pain Research (R01, R21)

The purpose of this Funding Opportunity Announcement (FOA) is to inform the scientific community of the pain research interests of the various Institutes and Centers (ICs) at the National Institutes of Health (NIH) and to stimulate and foster a wide range of basic, clinical, and translational studies on pain as they relate to the missions of these ICs. New advances are needed in every area of pain research, from the micro perspective of molecular sciences to the macro perspective of behavioral and social sciences. Although great strides have been made in some areas, such as the identification of neural pathways of pain, the experience of pain and the challenge of treatment have remained uniquely individual and unsolved. Furthermore, our understanding of how and why individuals transition to a chronic pain state after an acute injury is limited. Research to address these issues conducted by interdisciplinary and multidisciplinary research teams is strongly encouraged, as is research from underrepresented, minority, disabled, or women investigators. 

NOT-NS-18-008

The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is aimed at revolutionizing neuroscience through development and application of innovative technologies to map neural circuits, monitor and modulate their activity, and understand how they contribute to thoughts, sensations, emotions and behavior.  NIH has issued a variety of Funding Opportunity Announcements (FOAs) that will support projects that apply technologies to understand neural circuit function in the context of specific circuits, resulting in a diverse portfolio of research into the fundamental biology of nervous system function. 

The purpose of this announcement is to notify the research community that NIH welcomes BRAIN Initiative applications targeting central nervous system nociceptive and pain circuits, as appropriate to the goals and requirements of specific BRAIN Initiative FOAs.  Pain conditions represent an important public health problem and NIH continues to support research into pain pathologies through normal Institute and Center appropriations. However, pain and nociception are also components of normal nervous system function, and the BRAIN Initiative is committed to understanding pain circuits along with brain circuits underlying other sensory, motor, cognitive and emotional functions.  It is expected that the unique opportunities of the BRAIN Initiative will enable production of detailed maps of pain circuits, and the adoption of powerful new tools for monitoring and modulating pain circuit activity, leading to significant advances in the understanding of pain and nociception.

For a list of past and open BRAIN Initiative FOAs, see https://braininitiative.nih.gov/funding/.  For information on goals and requirements of specific BRAIN FOAs, contact Scientific/Program staff listed in the text of the respective announcements. 

NIH Funding Opportunities not focused primarily on pain

The following have pain or pain-related conditions in the objectives or targeted topics of interest

PAR-18-761 Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In Vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed)
This FOA provides funding to conduct pharmacodynamic, pharmacokinetic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development to treat neurological disorders that fall under the NINDS mission. Therapeutic agents may include but are not limited to small molecules, biologics or biotechnology-derived products. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the NINDS Cooperative Research to Enable and Advance Translational Enterprises for Biologics program (CREATE Bio) program for biologics, biotechnology products, Blueprint Neurotherapeutics Network for small molecules, or other translational programs.

PAR-18-762 Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Assay Development and Neurotherapeutic Agent Identification (R61/R33 Clinical Trial Not Allowed)
This funding opportunity announcement (FOA) encourages research grant applications to develop in vitro and/or ex vivo assays and conduct iterative screening efforts to identify and characterize potential therapeutic agents for neurological disorders. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the NINDS Cooperative Research to Enable and Advance Translational Enterprises for Biologics (CREATE Bio) program for biologics, biotechnology products, the Blueprint Neurotherapeutics Network (BPN) for small molecules, or other translational programs.

PAR-18-763 Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems and/or Pharmacodynamic Markers to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed)
This funding opportunity announcement (FOA) encourages the development and validation of: 1) animal models and human tissue ex vivo systems that recapitulate the phenotypic and physiologic characteristics of a defined neurological disorder and/or 2) clinically feasible pharmacodynamic markers for therapeutics designed to treat neurological disease.  The goal of this FOA is to promote a significant improvement in the translational relevance of animal models, ex vivo systems, and pharmacodynamic markers that will be utilized to facilitate the development of neurotherapeutics. Ideally, models, model systems and pharmacodynamic markers proposed in applications for this FOA would have the potential to provide feasible and meaningful assessments of efficacy following therapeutic intervention that would be applicable in both preclinical and clinical settings. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) focused on enabling the exploratory and early stages of drug discovery.   

PAR-18-548 Clinical Validation of a Candidate Biomarker for Neurological Disease (U44 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II clinical trials and beyond). 

PAR-18-549, Analytical Validation of a Candidate Biomarker for Neurological Disease (U44 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to support applications from Small Business Concerns (SBCs) to perform rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines.  Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use.  This FOA assumes that 1) a candidate biomarker has already been identified, 2) assay technology has already been developed, and 3) a working hypothesis regarding context of use is in place.  The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II clinical trials and beyond).

PAR-18-550 Analytical Validation of a Candidate Biomarker for Neurological Disease (U01 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to support rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines.  Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use.  This FOA assumes that 1) a candidate biomarker has already been identified, 2) assay technology has already been developed, and 3) a working hypothesis regarding context of use is in place.  The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II clinical trials and beyond).

PAR-18-664 Clinical Validation of a Candidate Biomarker for Neurological Disease (U01 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II clinical trials and beyond).

 

PA-18-502, PA-18-503 Advancing the Science of Geriatric Palliative Care (R01, R21)

This Funding Opportunity Announcement (FOA) encourages research grant applications focused on palliative care in geriatric populations. This FOA covers studies in a variety of settings including hospitals (and specific sites within hospitals including specialty medical or surgical wards, intensive care units, and emergency departments), post-acute care settings, outpatient clinics and doctors' offices, patients' homes and other residential settings, assisted living facilities, nursing homes, hospices, and other healthcare or community settings. This FOA encourages both prospective studies and analyses of existing datasets, health and medical records, claims data, or other sources. Leveraging ongoing cohorts, intervention studies, networks, data and specimen repositories, and other existing research resources and infrastructure are encouraged. Study designs may include observational approaches, quasi-experimental designs, and interventional studies.    

PA-18-376, PA-18-474, PA-18-384 Self-Management for Health in Chronic Conditions (R01, R15, R21)

 The purpose of this Funding Opportunity Announcement (FOA) is to encourage research that seeks to build the science of self-management for health in chronic conditions. This FOA focuses on self-management as a mainstream science to reduce the burden of chronic illnesses/conditions.

 

PA-18-151 PA-18-168 Chronic Illness Self-Management in Children and Adolescents (R01, R21)

The purpose of this Funding Opportunity Announcement (FOA) is to encourage exploratory/developmental research to improve self-management and quality of life in children and adolescents with chronic conditions. Managing a chronic condition is an unremitting responsibility for children and their families. Children with a chronic condition and their families have a long-term responsibility for self-management. This FOA encourages research that takes into consideration various factors that influence self-management such as individual differences, biological and psychological factors, family/caregivers and sociocultural context, family-community dynamics, healthcare system factors, technological advances, and the role of the environment.

PA-18-139, PA-18-157, PA-18-471 Innovative Questions in Symptom Science and Genomics (R01, R21, R15)

The purpose of this initiative is to optimize innovation, insight and cutting edge conceptual and technological breakthroughs by catalyzing research that emanates from the identified innovative questions in symptom and genomic nursing science. These innovative questions are reflective of broad domains from which more specific novel hypotheses or problems to be solved can be derived.  

PA-18-140, PA-18-158 Applying Metabolomics to Drive Biomarker Discovery in Symptom Science (R01, R21)

The purpose of this initiative is to encourage applications on biomarker discovery that utilize metabolomics approaches to advance the understanding, assessment and management of symptoms.

PA-18-055, PA-18-073, PA-18-074  Behavioral & Integrative Treatment Development Program (R01, R34, R03)

R01: The purpose of this FOA is to encourage behavioral intervention development research to test efficacy, conduct clinical trials, examine mechanisms of behavior change, determine dose-response, optimize combinations, and/or ascertain best sequencing of behavioral, combined, sequential, or integrated behavioral and pharmacological (1) drug abuse treatment interventions, including interventions for patients with comorbidities, in diverse settings; (2) drug abuse treatment and adherence interventions for use in primary care; (3) drug abuse treatment and adherence interventions that utilize technologies to boost effects and increase implementability; (4) interventions to prevent the acquisition or transmission of HIV infection among individuals in drug abuse treatment; (5) interventions to promote adherence to drug abuse treatment, HIV and addiction medications; and (6) interventions to treat chronic pain. Research of interest includes but is not limited to Stage II and Stage III efficacy research.

R34: The purpose of this FOA is to encourage investigators to propose discrete well-defined projects that can be completed within three years. Projects of interest fall within the research domain of behavioral or integrated (e.g., behavioral and pharmacological) interventions targeting: (a) substance abuse; (b) prevention of acquisition or transmission of HIV infection among individuals in substance abuse treatment; (c) promotion of adherence to substance abuse treatment, HIV and addiction medications; and (d) chronic pain. Specific examples include, but are not limited to studies focusing on: 1) Stage I intervention generation; 2) Stage I pilot or feasibility – and both should include the development of putative targets/ moderators, mediators, and change mechanisms; (3) Stage I studies to generate or refine substance abuse treatment or adherence interventions for use in primary care; (4) Stage I research to boost effects and increase implementability of interventions with creative use of technology or other means.

R03: The purpose of this FOA is to encourage investigators to propose discrete well-defined projects that can be completed within two years. Projects of interest fall within the research domain of behavioral or integrated (e.g., behavioral and pharmacological) interventions targeting: (a) substance abuse; (b) prevention of acquisition or transmission of HIV infection among individuals in drug abuse treatment; (c) promotion of adherence to drug abuse treatment, HIV and addiction medications; and (d) chronic pain. Specific examples include, but are not limited to studies focusing on: 1) Stage I intervention generation; 2) Stage I pilot or feasibility – and both should include the development of putative moderators, mediators, and change mechanisms; (3) Stage I studies to generate or refine drug abuse treatment or adherence interventions; (4) Stage I research to boost effects and increase implementability of interventions with creative use of technology or through other means.

PA-18-058, PA-18-076 Prescription Drug Abuse (R01, R21)

The National Institute on Drug Abuse (NIDA) encourages applicants to develop innovative research applications on prescription drug abuse, including research to examine the factors contributing to prescription drug abuse; to characterize the adverse medical, mental health and social consequences associated with prescription drug abuse; and to develop effective prevention and service delivery approaches and behavioral and pharmacological treatments. Applications to address these issues are encouraged across a broad range of methodological approaches including basic science, clinical, epidemiological, and health services research to define the extent of the problem of prescription drug abuse, to characterize this problem in terms of classes of drugs abused and combinations of drug types, etiology of abuse, and populations most affected (including analyses by age group, race/ethnicity, gender, and psychiatric symptomatology). Studies on individual- and patient-level factors, prescriber factors, and/or health system factors are encouraged, as are studies on all classes of prescription drugs with high abuse liability, including analgesics, stimulants, sedative/hypnotics and anxiolytics. Researchers are further encouraged to study the relationship between the prescription medication, the indication for which the medication was prescribed (e.g., pain, sleep disorder, anxiety disorder, obesity), and the environmental and individual factors contributing to abuse.

PAR-18-297,  PAR-18-030 NIA Program Project Applications

The National Institute on Aging invites the submission of investigator-initiated program project (P01) applications. The applications should address scientific areas relevant to the NIA mission. Each application submitted to this FOA must include at least three related research projects that share a common central theme, focus, and/overall objective and an administrative core to lead the project.

PAR-18-113 Center of Excellence for Research on Complementary and Integrative Health (P01 Clinical Trial Optional)

This funding opportunity announcement (FOA) encourages the submission of applications that requires multi-project, synergistic collaboration between outstanding scientists that blends multiple research approaches by multi-disciplinary research teams. This Center of Excellence for Research on Complementary and Integrative Health (CERCIH) program is designed to support three or more highly meritorious projects that can offer significant scientific advantages and "synergy" that could not be achieved by supporting the same projects as individual research grants. Each CERCIH must be focused on questions of high relevance to the mission of NCCIH. Applications in response to this FOA may propose to involve human participants in mechanistic studies, but this FOA will not support clinical trials of efficacy or effectiveness.

PA-18-409, PA-18-408  Research Grants Using the Resources from the Osteoarthritis Initiative (OAI) (R01 Clinical Trial Not Allowed, R21 Clinical Trial Not Allowed)

 This Funding Opportunity Announcement (FOA) encourages applications for research awards that are focused on the use of the Osteoarthritis Initiative (OAI) database, clinical data and images.  This FOA seeks to expand the use of these resources by investigators in the broader research community.  The publication of this FOA to the research community indicates to investigators and peer reviewers the importance that the NIAMS and others have placed on the use of the OAI resources.    

PAR-16-443 Drug Abuse Dissertation Research (R36)

The goal of this FOA is to enhance the diversity of the drug abuse research workforce by providing dissertation awards on topics related to the study of basic and clinical neuroscience, development, epidemiology, prevention, treatment, services, or women and sex/gender differences as they relate to drug abuse. This support will enhance the pool of highly talented drug abuse scientists who conduct research within the funding priority areas (http://www.drugabuse.gov/funding/funding-priorities) or in the NIDA strategic plan (https://www.drugabuse.gov/about-nida/2016-2020-nida-strategic-plan). Applications are encouraged from doctoral candidates in a variety of academic disciplines and programs. This program will ultimately facilitate the entry of promising new investigators into the field of drug abuse research and promote transdisciplinary collaborations. This award is for up to two years of support for the completion of the doctoral dissertation research project.

PAR-16-085 NIA Clinical Research Project Planning Grant Program (R34)

The NIA is committed to identifying effective treatments for diseases and conditions associated with aging and to ascertaining the associated health outcomes by supporting robust, well-planned and designed, and well-executed clinical trials and clinical research projects. This funding opportunity announcement (FOA) aims to support the planning activities needed for the successful execution of clinical trials and clinical research projects, including protocol, Manual of Procedures (MOP), data collection forms, and data and safety monitoring plan development as recommended by the NIA Clinical Research Study Investigator's Toolbox (http://www.nia.nih.gov/research/dgcg/clinical-research-study-investigators-toolbox/startup).

PAR-16-041PAR-16-042  Drug Discovery for Nervous System Disorders (R01, R21)

This Funding Opportunity Announcement (FOA) encourages research grant applications directed toward the discovery and preclinical testing of novel compounds for the prevention and treatment of nervous system disorders.