Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R01 Clinical Trial Optional)

The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is inviting applications for its research grant opportunity titled "Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R01 Basic Experimental Studies with Humans Required)." This initiative supports basic experimental studies involving humans that also meet the NIH definition of a clinical trial. The focus is on understanding the mechanistic effects of non-invasive brain stimulation (NIBS) on cognitive, behavioral, and neurobiological markers relevant to substance use disorders (SUD). This Notice of Funding Opportunity (NOFO) is aimed at identifying and validating novel NIBS targets and elucidating the associated cognitive and neurobiological responses that may precede clinical outcomes such as reduced craving or substance use. Eligible studies must prospectively assign participants to conditions and assess outcomes to understand the fundamental aspects of phenomena, without direct applications toward products or clinical processes. Applications can include research on technologies like Transcranial Magnetic Stimulation (TMS) and Transcranial Direct or Alternating Current Stimulation (tDCS, tACS). The research should contribute to a mechanistic understanding of SUD-related neural circuitry and provide insights that can inform future clinical trial designs. Applications not aligned with the scope, such as those focused exclusively on alcohol use disorder or not proposing basic human experimental studies, will be returned without review. The funding instrument is a grant, with budgets reflecting the actual needs of proposed projects. NIDA expects to commit $1.5 million annually for fiscal years 2024, 2025, and 2026, supporting up to six awards across this and companion NOFOs. The maximum project duration is five years. Applications are accepted on specific due dates—January 16 and August 14—through 2026. Letters of intent are due 30 days before the application deadline. The new expiration date for this opportunity is May 24, 2025. Eligible applicants include a wide range of domestic and foreign institutions such as higher education institutions, nonprofits, for-profit entities, and governmental bodies including state, county, and tribal governments. There is no cost-sharing requirement. Applications must comply with NIH submission protocols, and must be submitted electronically through Grants.gov, NIH ASSIST, or institutional systems. Compliance with NIH Data Management and Sharing policies is required. Evaluation will follow NIH peer review procedures and criteria, including significance, innovation, investigators' qualifications, and study design. Applications must also address data management, human subjects protection, and inclusion of diverse populations. Contact for scientific inquiries is Dr. John Fedota at john.fedota@nih.gov, and grants management questions should be directed to nidagmbemail@nida.nih.gov.