Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R61/R33 Clinical Trial Optional)

The Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R61/R33 Clinical Trial Optional) is a funding opportunity provided by the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), under the U.S. Department of Health and Human Services. This initiative aims to support exploratory and developmental research into new mechanisms of non-invasive brain stimulation (NIBS) to treat substance use disorders (SUD). The program focuses on identifying novel stimulation targets and understanding neurobiological, cognitive, and behavioral responses that might precede clinical improvements like reduced substance use. The grant uses the R61/R33 Phased Innovation Award mechanism, which provides up to two years of initial R61 support followed by up to three years of R33 funding upon meeting specified milestones. Projects must present a clear transition plan with measurable milestones to progress from the R61 to R33 phase. NIDA intends to invest $1.5 million per year in FY 2024, 2025, and 2026 to fund up to six awards through this and related companion funding announcements. Applicants are encouraged to focus on under-researched brain stimulation targets beyond common areas like the dorsolateral prefrontal cortex, and to explore intermediate indicators of treatment success. Applications that do not clearly define milestones, do not focus on SUD, or focus exclusively on alcohol use disorder will not be reviewed. Both clinical trials and non-clinical studies are eligible under this opportunity, provided they adhere to NIH policies and review criteria. Eligible applicants include higher education institutions (public and private), nonprofits, for-profit organizations, local and state governments, federally recognized and non-recognized tribal entities, foreign institutions, and other entities like school districts and faith-based organizations. Foreign and non-domestic U.S. institutions are also eligible. Applicants must ensure all required registrations (SAM, eRA Commons, Grants.gov) are completed prior to application. Applications are due at 5:00 PM local time of the applicant organization, with upcoming deadlines on August 14, 2024, January 16, 2025, and continuing semi-annually through August 2026. A letter of intent is requested 30 days prior to the due date. Applications should be submitted via ASSIST, Grants.gov Workspace, or an institutional system-to-system solution, and must comply with SF424 (R&R) Application Guide requirements, including detailed research strategies, human subject protections, and data management plans. Evaluation criteria include the significance, innovation, and approach of the proposed research, the qualifications of investigators, and the scientific environment. Applications will undergo NIH peer review and be assessed for overall impact, feasibility, and relevance to program priorities. Funding decisions will also consider milestone success, program fit, and available budget. For inquiries, applicants can contact Dr. John Fedota at john.fedota@nih.gov or 301-402-0812.