The funding opportunity titled “Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R01 Clinical Trial Optional)” is sponsored by the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH). This opportunity invites clinical research applications that aim to identify and validate new non-invasive brain stimulation (NIBS) targets and investigate substance use disorder (SUD)-related neurobiological, cognitive, and behavioral responses to NIBS. The overarching goal is to understand mechanisms of neuromodulation and its influence on SUD treatment outcomes.

The initiative supports mechanistic studies that investigate novel targets for neuromodulation using techniques such as Transcranial Magnetic Stimulation and Transcranial Direct or Alternating Current Stimulation. These studies are expected to explore how stimulation at new cortical sites affects large-scale brain networks and how these effects relate to SUD-relevant cognitive and behavioral responses. Through such research, the NIH hopes to establish a stronger scientific basis for designing future clinical trials and enhance the precision of treatment interventions.

Funding is intended for new or resubmission applications proposing research that seeks to identify novel stimulation targets and investigate their impact on neural circuits, behavior, and SUD-specific outcomes. Up to six awards may be made each year from FY 2024 to FY 2026 with a total budget of $1.5 million annually across this and three related NOFOs. There is no specified budget ceiling for individual awards, though budgets must be commensurate with the proposed scope of work. Project durations may not exceed five years.

Eligible applicants include higher education institutions, nonprofits, small and large businesses, state and local governments, tribal entities, regional organizations, public housing authorities, and some foreign entities. Applications focusing exclusively on alcohol use disorder or those not addressing SUD-relevant targets or responses to NIBS are not eligible. Applicants must complete several registrations, including SAM, eRA Commons, and Grants.gov, prior to submission.

A letter of intent is requested 30 days prior to each application deadline, although it is not mandatory. Application due dates occur semiannually on January 16 and August 14, with the final deadline being August 14, 2026. Reviews and funding decisions follow standard NIH cycles. Applications must be submitted electronically via one of the accepted systems (ASSIST, Grants.gov Workspace, or institutional S2S). Strict adherence to the NIH SF424 Application Guide is required.

Applications will be reviewed for scientific merit, innovation, investigator capability, and feasibility of study design. For clinical trials, reviewers will also evaluate recruitment plans, data management, ethical considerations, and data sharing. Applications deemed scientifically meritorious and aligned with NIDA’s priorities may receive funding. Questions related to scientific content should be directed to Dr. John Fedota at john.fedota@nih.gov.