Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)
ID: 357987Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $5M

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/357987

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-328.html
Timeline
    Description

    The National Institutes of Health (NIH) 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 that support a diverse range of preclinical and clinical projects, with the goal of advancing medication studies toward FDA approval, emphasizing the importance of innovative approaches to drug misuse and addiction treatment. Eligible applicants include a variety of institutions, such as higher education entities and community organizations, with funding available up to $5 million per year for projects lasting up to three years. Interested parties can find more information and submit inquiries via grantsinfo@nih.gov, with applications due by August 11, 2025.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-328-Full-Announcement.html
    PAR-25-328.html
    The National Institutes of Health (NIH), through the Department of Health and Human Services, has issued a funding opportunity aimed at advancing the development of medications for Substance Use Disorders (SUDs) via the Grand Opportunity in Medications Development program. This funding opportunity, identified as PAR-25-328, supports research projects from preclinical stages through to various phases of clinical trials, with an emphasis on the prompt progression toward FDA approval. Key goals include enhancing knowledge and approaches for prevention, diagnosis, and treatment related to drug misuse, addiction, and associated health outcomes. Eligible applicants include higher education institutions and various government organizations, and the maximum budget per project can reach $5 million annually, with a project duration of up to three years. A unique requirement of this NOFO is the Plan for Enhancing Diverse Perspectives (PEDP), designed to promote inclusivity within research teams and participant recruitment, which will be part of the application review process. Applications that overlook this PEDP will be deemed incomplete. The comprehensive review process considers scientific merit and the potential impact of proposed projects, ensuring detailed compliance with NIH policies throughout the funding lifecycle.
    Similar Opportunities
    Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)
    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.
    Development of Medications to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is offering a funding opportunity for the development of medications aimed at preventing and treating substance use disorders (SUDs) and overdose. This initiative is structured into two phases: the UG3 phase focuses on achieving specific milestones within a two-year period, while the UH3 phase extends support for an additional three years for projects that successfully meet the UG3 milestones. Given the urgent need for effective treatments in light of rising overdose deaths, particularly from synthetic opioids and stimulants, this funding opportunity emphasizes innovative research methodologies and the effective application of existing medications. Interested applicants can seek funding of up to $3 million annually for a maximum of five years, with applications due by August 11, 2025. For further inquiries, contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-25-329.html.
    Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), has announced a funding opportunity aimed at the development of medications to prevent and treat opioid and stimulant use disorders and overdose. This initiative seeks innovative preclinical and clinical research projects that can lead to FDA-approved therapies, focusing on areas such as prevention of substance use initiation, treatment adherence, and reduction of overdose risks. With a maximum funding amount of $3 million per year over a project period of five years, applicants are encouraged to submit proposals that demonstrate their capability to manage the research effectively, adhering to detailed application instructions. Interested parties can find more information and application details at the NIH grants website, with the application deadline set for September 1, 2025.
    Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R01 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R01 Clinical Trial Optional)" aimed at advancing clinical research in the field of substance use disorders (SUD). The primary objective is to identify and validate novel targets for non-invasive brain stimulation (NIBS) and to explore the neurobiological, cognitive, and behavioral responses associated with NIBS that may lead to improved clinical outcomes such as reduced cravings or drug use. This initiative is crucial for enhancing understanding and treatment options for SUD through innovative research methodologies. Funding of up to $1.5 million is available for selected projects over a maximum project period of five years, with applications due by August 14, 2026. Interested applicants can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries and are encouraged to review the detailed application instructions available at the provided link.
    Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)
    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.
    Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)
    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.
    Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R61/R33 Basic Experimental Studies with Humans Required)
    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.
    Exploratory Clinical Neuroscience Research on Substance Use Disorders (R61/R33 Clinical Trial Optional)
    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.
    Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R01 Basic Experimental Studies with Humans Required)
    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 (R01 Basic Experimental Studies with Humans Required)," aimed at advancing research on non-invasive brain stimulation (NIBS) as a treatment for substance use disorders (SUDs). This initiative encourages innovative proposals that explore novel NIBS targets and neurobiological responses, with a focus on understanding the mechanisms underlying SUDs through clinical trials involving human subjects. The NIH plans to allocate $1.5 million annually over three years to fund approximately six grants, with applications due by January 16, 2024. Interested applicants can find more information and guidance on the required Plan for Enhancing Diverse Perspectives (PEDP) at the provided link, and inquiries can be directed to NIH Grants Information at grantsinfo@nih.gov.
    Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)" aimed at advancing the development of Digital Therapeutics (DTx) for treating Substance Use Disorders (SUDs). This initiative seeks to support the creation of safe and effective clinical-grade digital platforms that can deliver therapeutic treatments, particularly for conditions that currently lack FDA-approved medications. The funding mechanism involves a two-phase cooperative agreement, with the UG3 phase focusing on initial milestones and design testing for up to two years, followed by the UH3 phase, which can extend for an additional three years upon successful completion of the UG3 phase. Eligible applicants include a diverse range of organizations, such as educational institutions, tribal governments, and community-based organizations. The application process opens on February 26, 2024, with multiple deadlines extending through late 2026. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.