Combined Neuromodulation and Behavioral Treatment Algorithm Development for Stimulant Use Disorder (StUD) Enriched for Vulnerable Phenotype (U01 Clinical Trial Required)
ID: 355169Type: 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/355169

Additional Information

http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-057.html
Timeline
    Description

    The National Institutes of Health (NIH) is inviting proposals for a funding opportunity aimed at developing a combined neuromodulation and behavioral treatment algorithm for Stimulant Use Disorder (StUD), particularly focusing on vulnerable populations exhibiting high impulsivity and cognitive dysfunction. The initiative seeks to integrate non-invasive brain stimulation techniques, such as transcranial magnetic stimulation, with effective behavioral interventions like cognitive behavioral therapy, to create FDA-approved treatment solutions for StUD. Up to $2 million is available to fund three to five awards, with individual project budgets capped at $500,000 per year, and applications are due by November 28, 2024. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    RFA-DA-25-057-Full-Announcement.html
    RFA-DA-25-057.html
    The National Institutes of Health (NIH) is soliciting proposals for a new funding opportunity aimed at developing a combined neuromodulation and behavioral treatment algorithm for Stimulant Use Disorder (StUD), specifically targeting vulnerable phenotypes associated with high impulsivity and cognitive dysfunction. The initiative, under Funding Opportunity Number RFA-DA-25-057, encourages the pairing of non-invasive brain stimulation techniques (such as transcranial magnetic stimulation) with effective behavioral interventions (like cognitive behavioral therapy). The ultimate goal is to advance treatment strategies that can lead to FDA-approved device-based solutions for StUD. Applications must propose clinical trials that evaluate the efficacy of these combined treatments, focusing on critical factors such as treatment response, remission, and relapse prevention, particularly for patients deemed treatment-refractory. Up to $2 million will be available to fund three to five awards, with individual budgets capped at $500,000 per year. Project periods can extend up to five years, and all applications are due by November 28, 2024, with an earlier start date of November 27, 2024, for funded projects. The initiative underscores the urgency of improving treatment outcomes for individuals struggling with stimulant-related substance use disorders.
    Similar Opportunities
    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.
    Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R61/R33 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 (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 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.
    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.
    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.
    Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Neuromodulation/Neurostimulation Device Development for Mental Health Applications," aimed at advancing the development of innovative brain stimulation devices for mental health disorders. This initiative seeks applications that either create novel brain stimulation technologies or significantly enhance existing FDA-approved devices through improvements in hardware and software, focusing on increased spatiotemporal precision and multi-focal, closed-loop approaches. The program is particularly important for addressing limitations in current mental health treatments and fostering technological innovation in this field. Interested applicants can apply for grants up to $275,000 for a two-year project period, with applications due by January 7, 2028. 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-25-286.html.
    Optimizing Treatment Strategies for Adult Attention-Deficit Hyperactivity Disorder (ADHD) (R01 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is announcing a forthcoming funding opportunity titled "Optimizing Treatment Strategies for Adult Attention-Deficit Hyperactivity Disorder (ADHD) (R01 Clinical Trial Required)." This initiative aims to support the development of evidence-based treatment approaches for adult ADHD that extend beyond traditional stimulant medications, incorporating nonstimulant medications, psychosocial interventions, and device-based treatments, particularly in cases where stimulant therapy is inadequate or intolerable. The program is crucial for addressing the treatment needs of adults with ADHD, especially considering the prevalence of comorbid conditions. The estimated total funding for this program is $3 million, with four awards expected to be made. Interested applicants are encouraged to prepare their proposals ahead of the anticipated synopsis posting on August 15, 2025, with applications due by October 15, 2025, and awards expected to be announced by July 1, 2026. For further inquiries, potential applicants can contact the NIH at NIMHinitiatives@mail.nih.gov.
    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.
    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.