Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)
ID: 355380Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $500K

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/355380

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-023.html
Timeline
    Description

    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 device-based treatments for Substance Use Disorders (SUDs). This initiative seeks to support both pre-clinical and clinical development phases through a cooperative agreement format, which includes an initial UG3 phase of up to two years, followed by a potential UH3 phase lasting three additional years, contingent upon successful milestone achievement. The program emphasizes innovative approaches to understanding device mechanisms and treatment outcomes, particularly for SUDs lacking effective current treatments, and requires proposals to include quantifiable milestones and collaboration with NIH staff. Interested applicants can find more information and submission guidelines at the provided link, with an award ceiling of $500,000 and a closing date for applications set for August 13, 2026. For inquiries, applicants may contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-023.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is issuing a funding opportunity (PAR-25-023) aimed at accelerating the development of device-based treatments for Substance Use Disorders (SUDs), including neuromodulatory devices. This initiative seeks to support pre-clinical and clinical development phases through a UG3/UH3 cooperative agreement format, which comprises two phases: the initial UG3 phase lasting up to two years, followed by a potential UH3 phase for three additional years, contingent upon successful milestone achievement. The funding focuses on understanding device mechanisms and potential treatment outcomes for various SUDs, especially for conditions lacking current effective treatments. Proposals must include quantifiable milestones, adhere to regulatory requirements, and emphasize collaboration with NIH staff throughout the process. Additionally, submission guidelines highlight the importance of registration in various electronic systems and adherence to specific criteria for application review. The program encourages innovative approaches, the evaluation of device efficacy, and exploration of the relationship between device use and behavioral changes in patients suffering from SUDs.
    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.
    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.
    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.
    Developing Digital Therapeutics 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 "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.
    Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R61/R33 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 (R61/R33 Clinical Trial Optional)" aimed at encouraging clinical research to identify and validate novel targets for non-invasive brain stimulation (NIBS) related to substance use disorders (SUD). This initiative seeks exploratory and developmental studies that may involve significant risks but have the potential to lead to breakthroughs in understanding the neurobiological and behavioral responses associated with SUD treatment. The funding opportunity includes a budget cap of $600,000 for the R61 phase, with a total of up to $1.5 million available across multiple awards, and requires applicants to submit a Plan for Enhancing Diverse Perspectives (PEDP). Interested applicants should note that the application period opens on December 16, 2023, and closes on August 14, 2026; for further inquiries, they can contact NIH Grants Information at grantsinfo@nih.gov.
    Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R01 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 (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.
    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.
    Medical Devices for Pediatric Population Affected by Substance Use and Addiction (R43 - Clinical Trials Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Medical Devices for Pediatric Population Affected by Substance Use and Addiction," aimed at supporting small businesses through the Small Business Innovation Research (SBIR) grant program. This initiative invites applications for the research and development of medical devices specifically designed for individuals aged 0-21 who are affected by substance use and addiction, addressing a critical gap in pediatric healthcare. The program seeks innovative proposals for digital therapeutics, diagnostic tools, and wearable devices, with an expected funding allocation of approximately $2 million to support four or five Phase I awards, each up to $400,000. Applications are due by February 26, 2025, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    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.
    Exploratory Clinical Neuroscience Research on Substance Use Disorders (R61/R33 Basic Experimental Studies with Humans (BESH) Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a Notice of Funding Opportunity (NOFO) for exploratory clinical neuroscience research focused on substance use disorders (SUD) through the R61/R33 phased innovation award mechanism. This funding opportunity aims to support clinical research proposals that investigate the neurobiological mechanisms underlying SUD, allowing for up to five years of funding, with the R61 phase dedicated to initial concept testing and the R33 phase contingent upon achieving specific milestones. The initiative is crucial for advancing understanding of substance abuse impacts in the U.S., encouraging innovative research on topics such as neural circuitry and cognitive factors influencing addiction. Interested applicants, including various educational and nonprofit institutions, can find more details and submit applications by the closing date of May 7, 2026, with no cost-sharing requirement. 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-23-158.html.