Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)
ID: 352661Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

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/352661

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-24-064.html
Timeline
    Description

    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 accelerating the development of digital therapeutics (DTx) to treat substance use disorders (SUDs). This initiative seeks to support the creation of clinical-grade mobile, web, or software-based platforms that are safe and effective for SUD treatment, with a focus on obtaining FDA authorization for these interventions. The funding follows a two-phase structure, with the UG3 phase allowing for up to two years of initial development and milestone achievement, and the UH3 phase extending up to three years based on successful progression, with no budget limit for the latter phase and a cap of $500,000 for the UG3 phase. Interested applicants, including various educational institutions and organizations, must submit their proposals by February 26, 2024, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-24-064-Full-Announcement.html
    PAR-24-064.html
    The Department of Health and Human Services, through the National Institute on Drug Abuse (NIDA), is issuing a funding opportunity for developing Digital Therapeutics (DTx) aimed at treating Substance Use Disorders (SUDs). The funding—identified by opportunity number PAR-24-064—focuses on accelerating DTx development, with an emphasis on obtaining FDA authorization. The grant follows a two-phase structure: the UG3 phase (up to two years) for initial development and milestone achievement, and the UH3 phase (up to three years) contingent upon the successful progression of the UG3 phase. Key objectives include advancing clinical-grade mobile, web, or software interventions tailored to SUD treatment. Applicants must devise measurable milestones and regulatory strategies while partnering with relevant FDA offices for guidance. There will be no limit on the budget for the UH3 phase, with specified annual budgets capped at $500,000 for the UG3 phase. The program encourages diverse applicants, including higher education institutions, nonprofits, and for-profit organizations. The deadline for submission is February 26, 2024, with various review metrics assessing significance, innovation, and research approach. This NOFO exemplifies a commitment to innovative solutions for addressing the critical public health issue of substance use disorders.
    Similar Opportunities
    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.
    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.
    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.
    Seeking Products to Address Social Needs impacting Substance Use Disorders (SUD) (R41/R42 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity aimed at small business concerns (SBCs) to develop technologies that address health-related social needs impacting substance use disorders (SUD), excluding alcohol use disorder. This initiative, titled "Seeking Products to Address Social Needs impacting SUD," invites applications for Small Business Technology Transfer (STTR) grants under phases I and II, with a total funding amount of $1.3 million available for four awards in FY 2025. The focus is on leveraging innovative technologies, such as telemedicine and mobile health applications, to improve conditions like housing instability and food insecurity that influence SUD outcomes. Interested applicants must comply with specific eligibility criteria and application guidelines, with a submission deadline of March 13, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the full announcement at https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-047.html.
    Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
    Active
    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.
    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.
    Seeking Products to Address Social Needs impacting Substance Use Disorders (SUD) (R43/R44 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity aimed at supporting small business concerns (SBCs) in developing technologies that address health-related social needs impacting substance use disorders (SUD), excluding alcohol use disorder. The initiative seeks innovative products that tackle core social determinants such as housing instability, food insecurity, and personal safety, with an emphasis on integrating technology like telemedicine and health applications to enhance access and reduce treatment barriers for at-risk populations. A total funding amount of $2 million is available, with specific allocations for Phase I and Phase II applications, and the deadline for submission is March 13, 2026, with letters of intent recommended 30 days prior. For further inquiries, interested applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the full announcement at https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-048.html.
    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.
    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.
    Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R01 Clinical Trial Optional)
    Active
    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.