Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
ID: 343322Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $3M

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), has announced a funding opportunity for the development of medications aimed at preventing and treating opioid and stimulant use disorders and overdose. This initiative, structured as a cooperative agreement (UG3/UH3), seeks innovative preclinical and clinical research proposals that address significant gaps in the treatment landscape, particularly for opioid use disorder (OUD) and psychostimulant use disorder (PsUD). The program is critical in responding to the ongoing overdose crisis and aims to facilitate the FDA's approval of novel pharmacotherapeutics, including new chemical entities and biologics, with a funding ceiling of $3 million per year over a maximum of five years. Interested applicants can find more information and guidelines at the NIH grants website and should direct inquiries to grantsinfo@nih.gov, with applications accepted until September 1, 2025.

    Point(s) of Contact
    Files
    Title
    Posted
    The Department of Health and Human Services, through the National Institutes of Health (NIH) and the National Institute on Drug Abuse (NIDA), has issued a funding opportunity aimed at the development of medications for preventing and treating opioid and stimulant use disorders and overdose. This cooperative agreement funding (UG3/UH3) encourages preclinical and clinical research that addresses crucial gaps in the treatment landscape, particularly with respect to opioid use disorder (OUD) and psychostimulant use disorder (PsUD). Key application dates include continuous submissions, scientific merit reviews occurring on specific dates, and a funding ceiling of $3 million yearly over a maximum of five years. The program seeks innovative research proposals targeting potential pharmacotherapeutics, including new chemical entities and biologics. Milestones will be essential for transitioning projects from the UG3 to the UH3 phase, as well as ensuring the effectiveness and safety of new medications. The overarching goal is to respond to the escalating overdose crisis and to facilitate the FDA's approval of novel treatments that would improve public health outcomes. Applications should adhere strictly to NIH guidelines and aim for a diverse pool of applicants to reflect varied perspectives in research.
    Similar Opportunities
    Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is offering a funding opportunity titled "Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)" aimed at accelerating the development of medications for Substance Use Disorders (SUDs). This initiative encourages research applications for diverse preclinical and clinical projects that can expedite the FDA approval process for new treatments, addressing the significant public health need for effective therapies for conditions such as cocaine, methamphetamine, and cannabis use disorders. The program will provide cooperative agreements for projects lasting up to three years, with annual budgets capped at $5 million, and applications are accepted on a rolling basis with specific due dates for scientific merit review established throughout 2023 and 2024. Interested applicants can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries, and additional details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-22-202.html.
    Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R41/R42 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD)." This initiative invites Small Business Technology Transfer (STTR) grant applications from small business concerns proposing research projects aimed at developing innovative, FDA-regulated medical products to address the urgent needs of patients suffering from opioid and stimulant use disorders. The program is particularly focused on two scientific areas: pharmacotherapeutics and medical therapeutic and diagnostic devices, including software as a medical device, in response to the national crisis of substance use disorders. Grants of up to $300,000 are available, with a submission deadline of February 14, 2025, and interested applicants can find more information by contacting NIH Grants Information at grantsinfo@nih.gov or visiting the official announcement at https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-24-038.html.
    Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R43/R44 - Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for Small Business Innovation Research (SBIR) grants aimed at developing regulated therapeutic and diagnostic solutions for patients affected by Opioid Use Disorders (OUD) and Stimulant Use Disorders (StUD). This initiative encourages small businesses to propose research projects focused on the commercialization of novel, FDA-regulated medical products, specifically in the areas of pharmacotherapeutics and medical therapeutic and diagnostic devices, including software solutions. Given the urgent public health crisis highlighted by rising drug overdose fatalities, this funding aims to enhance treatment accessibility and efficacy for affected individuals and communities. Interested applicants can apply for a total funding amount of approximately $3 million, with a submission deadline of February 14, 2025. For further inquiries, contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov or visit the additional information link at http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-23-021.html.
    Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)" aimed at accelerating the development of innovative devices to treat Substance Use Disorders (SUDs). The initiative seeks proposals that focus on advancing neuromodulatory or neurophysiological devices through various stages of the FDA approval process, with an emphasis on understanding treatment mechanisms and their efficacy. Eligible applicants include a diverse range of organizations, such as academic institutions, nonprofits, and tribal governments, with a maximum budget of $500,000 per year for the UG3 phase, which lasts up to two years before transitioning to the UH3 phase for an additional three years. Applications will open on November 18, 2023, with awards expected to commence by December 2023; interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R33 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "HEAL Initiative: Translating Research to Practice to End the Overdose Crisis" (RFA-DA-23-054), aimed at supporting innovative research that bridges the gap between research findings and practical applications to combat the opioid overdose crisis. This initiative emphasizes the need for stigma-free, patient-centered care systems and focuses on understudied areas related to overdose prevention, requiring applicants to present preliminary data for significant projects within a maximum project period of five years and a budget of up to $750,000 in direct costs annually. The funding reflects a commitment to addressing health disparities and promoting effective addiction treatment and recovery solutions, with applications evaluated based on significance, innovation, feasibility, and stakeholder engagement. Interested applicants should note that the application deadline is March 20, 2025, and can direct inquiries to the NIH OER Webmaster at OERWebmaster03@od.nih.gov.
    Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R61/R33 Basic Experimental Studies with Humans Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment," aimed at encouraging clinical research to explore novel non-invasive brain stimulation (NIBS) targets for treating substance use disorders (SUD). This initiative seeks applications for exploratory and developmental studies that will identify and validate neurobiological, cognitive, and behavioral responses to NIBS, with the goal of understanding mechanisms that could lead to reduced cravings and substance use. The NIH plans to allocate $1.5 million in funding for fiscal years 2024-2026, with an award ceiling of $500,000 per project phase, and key submission dates starting December 16, 2023. Interested applicants can find more information and guidelines at the NIH grants website or contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R33 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "HEAL Initiative: Translating Research to Practice to End the Overdose Crisis," aimed at supporting research that translates findings into practical solutions for addressing the overdose crisis. This initiative encourages applications from a diverse range of organizations, including educational institutions and nonprofits, with a focus on developing stigma-free, patient-centered systems for addiction recovery and improving the quality of addiction treatment services. The NIH plans to commit approximately $10 million to fund grants, with an expected award ceiling of $750,000 for up to 12 awards, and applications will be accepted starting February 20, 2025, with a closing date of March 20, 2025. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the opportunity's webpage at https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-077.html.
    Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is offering a funding opportunity aimed at accelerating the development of device-based treatments for Substance Use Disorders (SUDs) under the UG3/UH3 Cooperative Agreement mechanism. This initiative invites applications focused on both pre-clinical and clinical development of neuromodulatory devices, with the goal of advancing these technologies through the FDA approval process. The funding is structured in two phases: the UG3 phase supports milestone achievements for up to $500,000 annually over two years, while the UH3 phase provides continued funding for projects that successfully meet these milestones for an additional three years. Interested applicants can find more information and application guidelines at the provided NIH link, with the submission deadline set for August 13, 2026.
    Exploratory Clinical Neuroscience Research on Substance Use Disorders (R61/R33 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Exploratory Clinical Neuroscience Research on Substance Use Disorders" (R61/R33), aimed at supporting innovative clinical research that explores the neurobiological mechanisms underlying substance use disorders (SUD). This initiative encourages applications that investigate neural circuitry and cognitive processes affecting substance use behavior, particularly in the context of the ongoing public health crisis related to SUDs, including the opioid epidemic. The R61/R33 mechanism allows for up to five years of funding, divided into an initial two-year R61 phase and a potential three-year R33 phase, contingent upon meeting specified milestones. Interested applicants can find more information and submit proposals by the application due date of March 13, 2026, and may contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "HEAL Initiative: Translating Research to Practice to End the Overdose Crisis" (RFA-DA-25-078), aimed at supporting research that transforms addiction treatment and care to combat the ongoing overdose crisis. This initiative encourages phased applications (R61/R33), where the R61 phase focuses on exploratory activities without the need for existing pilot data, while the R33 phase seeks to implement larger studies based on successful R61 milestones, emphasizing stigma-free and patient-centered approaches. With up to $10 million allocated for FY2026 and a maximum award period of six years, applicants must include a Plan for Enhancing Diverse Perspectives (PEDP) to ensure inclusivity, and applications are to be submitted through Grants.gov by the closing date of March 20, 2025. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.