Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R61/R33 Basic Experimental Studies with Humans Required)

The Department of Health and Human Services, through the National Institutes of Health (NIH) and specifically the National Institute on Drug Abuse (NIDA), has released a funding opportunity titled “Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R61/R33 Basic Experimental Studies with Humans Required).” This notice of funding opportunity (NOFO), designated RFA-DA-24-034, seeks to support clinical research aimed at identifying and validating novel targets for non-invasive brain stimulation (NIBS) for treating substance use disorders (SUD), along with understanding the neurobiological, cognitive, and behavioral responses to NIBS that precede clinical outcomes like reduced craving or substance use. This initiative promotes exploratory and developmental research through a phased award mechanism (R61/R33), which provides initial funding for up to two years for feasibility testing and development (R61 phase), followed by up to three years for expanded investigation (R33 phase), contingent on meeting pre-defined milestones. The research must meet NIH definitions for both basic research and a clinical trial and must involve experimental manipulations in human participants aimed at understanding fundamental aspects of phenomena without direct therapeutic intent. Eligibility is open to a wide range of applicant types including higher education institutions, nonprofit organizations, for-profit organizations (including small businesses), governmental entities at all levels, independent school districts, housing authorities, tribal organizations, faith-based and community organizations, regional organizations, and foreign institutions or components. Each applicant must have necessary registrations such as SAM, Grants.gov, eRA Commons, and a Unique Entity Identifier (UEI). The funding available totals $1.5 million annually for fiscal years 2024, 2025, and 2026, and up to six awards will be made across this NOFO and its companions. The maximum combined budget for the R61 phase is $600,000 in direct costs. The R33 phase has no specific budget cap but must reflect actual project needs. There is no requirement for cost-sharing or matching funds. Applications that do not align with the goals and milestones of the NOFO, or focus exclusively on alcohol use disorder or do not constitute basic experimental studies involving humans, will be considered non-responsive. The grant application process includes multiple submission cycles with due dates in January and August through 2026, with the next deadline being August 14, 2025. Letters of intent should be submitted 30 days prior to the due date. Applications must be submitted electronically through NIH's ASSIST system, Grants.gov Workspace, or an institutional system-to-system solution. Evaluation criteria include the significance, innovation, and approach of the study, the expertise of the investigators, and the research environment. Applications must include milestones that are specific, quantifiable, and clinically meaningful. For assistance, applicants may contact Dr. John Fedota at john.fedota@nih.gov or by phone at 301-402-0812 for scientific/research queries, or the NIDA Grants Management Office at nidagmbemail@nida.nih.gov for financial or administrative questions. Applicants are encouraged to reach out to program staff early in the application process to ensure responsiveness and alignment with the NOFO's objectives.