Notice NOT-OD-19-041 from the NIH Guide for Grants and Contracts

Notice NOT-AI-19-016 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-DA-19-035 from the NIH Guide for Grants and Contracts. This FOA is intended to solicit two-phase research applications to develop, adapt and test interventions and strategies to prevent initiation of opioid misuse and development of OUD in at-risk older adolescents and young adults (ages 16-30). The goal is to stimulate research studies conducted in populations and geographic areas most affected by the opioid crisis or with indicators of an emerging crisis. Of priority are studies that target older adolescents and young adults in health care settings (including primary care, surgical, orthopedic and other specialty care, dental care, emergency departments, urgent care, HIV/STI and reproductive health clinics, prenatal clinics, school-based health centers, federally qualified health centers, military medicine settings, occupational health settings), justice settings (including criminal justice, juvenile justice, as well as child welfare and other systems that cross with the justice system) and other systems and settings. Studies that include understudied at-risk older adolescent and young adult populations are strongly encouraged. Examples include, but are not limited to individuals in rural or reservation settings, women, veterans, and individuals with a history of polysubstance use or mental disorders.

Funding Opportunity RFA-NS-19-021 from the NIH Guide for Grants and Contracts. The Purpose of this FOA is to solicit cooperative agreement applications that propose clinical trials to establish the effectiveness of existing therapies and approaches for prevention and management of pain. 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 The overall goal is to inform clinicians about the effectiveness of interventions 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 Management Effectiveness Research Network.

Funding Opportunity RFA-RM-19-001 from the NIH Guide for Grants and Contracts. 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.

Funding Opportunity RFA-TR-19-005 from the NIH Guide for Grants and Contracts. 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. Please limit this field to a brief description of to page in length. Brevity is appreciated. This FOA is part of the of the NIHs 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

Funding Opportunity RFA-TR-19-003 from the NIH Guide for Grants and Contracts. Tissue 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 of the NIHs 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.

Funding Opportunity RFA-NS-19-020 from the NIH Guide for Grants and Contracts. 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.

Funding Opportunity RFA-MH-19-525 from the NIH Guide for Grants and Contracts. In April 2018, the National Institutes of Health (NIH) launched the HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. In response to this initiative, the National Institute of Mental Health (NIMH), in partnership with other NIH Institutes, proposes research to adapt the Collaborative Care Model (referred to henceforth as collaborative care) a specific service delivery model for treating mental/behavioral health conditions in primary care settings to meet the needs of individuals with opioid use disorders (OUDs) and co-occurring mental health conditions. Effectiveness clinical trials are envisioned to develop, optimize, implement, scale, and sustain collaborative models that offer Medication Assisted Treatment for OUD alongside indicated treatment for mental health conditions that commonly co-occur with OUD and are treatable in primary care.

Funding Opportunity RFA-AR-19-028 from the NIH Guide for Grants and Contracts. NIH has identified a set of research priorities reflecting urgent unmet needs across the lifespan, areas of promising scientific opportunity, and concrete strategies capable of providing rapid and durable solutions to the opioid crisis including improved understanding of the biological underpinnings of chronic pain and discovery and testing of new non-addictive pain treatments.

Funding Opportunity RFA-NS-19-016 from the NIH Guide for Grants and Contracts. 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 Funds 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.

Funding Opportunity RFA-DA-19-034 from the NIH Guide for Grants and Contracts. The purpose of this FOA is to fund a single coordinating center to formalize and centralize support for the HEAL Preventing Opioid Misuse and Opioid Use Disorder in Older Adolescents and Young Adults (ages 16-30) initiative administered by NIDA. The coordinating center will provide administrative and scientific, technical, and logistical support for coordination of common data elements, data harmonization, data sharing across projects; methodological and statistical support in the areas of study design, complex statistical analyses, economic analyses, implementation research; coordination of stakeholder and partnership engagement activities; developing and coordinating a HEAL prevention initiative publication and dissemination plan, providing logistical support for in-person meetings, conference calls, and webinars that include HEAL prevention grantees, funders and stakeholders. In addition, the coordinating center also will assist with collecting data on prevalence, incidence, risk and protective factors, and contextual factors in the identified populations and settings that will inform HEAL prevention research projects.

Funding Opportunity RFA-AT-19-006 from the NIH Guide for Grants and Contracts. The purpose of this FOA is to solicit applications to examine the impact of behavioral and social interventions designed to improve adherence to Medication Assisted Treatment (MAT) for persons with Opioid Use Disorders (OUD). Applications may address MAT initiation, implementation, and/or persistence by OUD patients. Descriptive and intervention research that address adherence determinants at more than one level levels of ecologic influence (including the patient, caregiver/family, providers and/or healthcare system, and community levels) are of higher priority. Attention to scientific rigor in all applications is paramount, with emphasis on appropriate sample sizes and valid outcome measures.

Funding Opportunity RFA-HL-19-028 from the NIH Guide for Grants and Contracts. This FOA aims to elucidate basic sleep and circadian mechanisms contributing to the risk of opiate use disorder (OUD), the pathobiology of opiate withdrawal, and that influence the response to medication-assisted treatment (MAT). Studies are needed to apply advances in understanding sleep and circadian biology to improving our understanding of OUD, the directionality of sleep and OUD interactions, and the opportunities to improve therapy and outcome. Multi-disciplinary, multiple-investigator teams combining expertise in sleep and circadian neurobiology with the neurobiology OUD and pharmacology of MAT are strongly encouraged. This FOA is only open to the study of OUD relevant mechanisms and pathobiology. The study of other drugs of abuse will not be responsive.

Notice NOT-TR-18-031 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-DK-18-030 from the NIH Guide for Grants and Contracts. 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 or 6 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.

Funding Opportunity RFA-DK-18-031 from the NIH Guide for Grants and Contracts. 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 or 6 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.

Funding Opportunity RFA-DA-19-025 from the NIH Guide for Grants and Contracts. The intersection of justice and community-based health systems is a critical target for addressing the opioid crisis. The National Institute on Drug Abuse intends to establish the Justice Community Opioid Innovation Network (JCOIN) using the cooperative agreement mechanism. The purpose of the network is to establish a national consortium of investigators examining promising interventions and other approaches that can improve the capacity of the justice system to effectively respond to the opioid epidemic. The structure of the network shall consist of three highly integrated components - (1) Clinical Research Centers (each center will propose a study to be executed in at least 5 research performance sites), (2) a single, central Coordination and Translation Center, and (3) a single, central Methodology and Advanced Analytics Resource Center. This FOA solicits applications for Clinical Research Centers. This FOA runs in parallel with companion FOAs that seek applications for a single Coordination and Translation Center (RFA-DA-19-024), and a single Methodology and Advanced Analytics Resource Center (RFA-DA-19-023).

Funding Opportunity RFA-DA-19-024 from the NIH Guide for Grants and Contracts. The intersection of justice and community-based health systems is a critical target for addressing the opioid crisis. The National Institute on Drug Abuse intends to establish the Justice Community Opioid Innovation Network (JCOIN) using the cooperative agreement mechanism. The purpose of the network is to establish a national consortium of investigators examining promising interventions and other approaches that can improve the capacity of the justice system to effectively respond to the opioid epidemic.

Funding Opportunity RFA-DA-19-023 from the NIH Guide for Grants and Contracts. The intersection of justice and community-based health systems is a critical target for addressing the opioid crisis. The National Institute on Drug Abuse intends to establish the Justice Community Opioid Innovation Network (JCOIN) using the cooperative agreement mechanism. The purpose of the network is to establish a national consortium of investigators examining promising interventions and other approaches that can improve the capacity of the justice system to effectively respond to the opioid epidemic. The structure of the network shall consist of three highly integrated components - (1) Clinical Research Centers (each center will propose a study to be executed in at least 5 research performance sites); (2) a single, central Coordination and Translation Center; and (3) a single, central Methodology and Advanced Analytics Resource Center. This FOA solicits applications for a Methodology and Advanced Analytics Resource Center. This FOA runs in parallel with companion FOAs that seek applications for Clinical Research Centers (RFA-DA-19-025), and a single Coordination and Translation Center (RFA-DA-19-024).