Exploratory Clinical Neuroscience Research on Substance Use Disorders (R61/R33 Clinical Trial Optional)

The Exploratory Clinical Neuroscience Research on Substance Use Disorders funding opportunity is administered by the National Institutes of Health (NIH), specifically through the National Institute on Drug Abuse (NIDA). This grant opportunity is part of the Department of Health and Human Services’ ongoing efforts to combat substance use disorders (SUDs) and supports exploratory and developmental clinical research aimed at understanding the neurobiological mechanisms underlying SUDs. This initiative aligns with public health priorities and addresses urgent needs in light of ongoing issues such as the opioid epidemic and rising use of other substances. The funding opportunity uses the R61/R33 Phased Innovation Award mechanism, supporting research over a combined five-year period, divided into up to two years for the R61 exploratory phase and up to three years for the R33 development phase. The research should focus on novel approaches to uncovering fundamental neural circuitry and behavioral patterns associated with SUD. Topics may include individual neural differences influencing addiction, the cognitive and behavioral aspects of substance use, and innovative uses of existing methodologies to explore new scientific areas. Approximately half of the awarded R61 phase projects are expected to transition to the R33 phase, based on milestone achievements and programmatic priorities. Applicants must propose clear, quantitative milestones to transition from the R61 to the R33 phase. Preliminary data is not required but can be included if available. Funding for the R61 phase may not exceed $500,000 in direct costs for the two years. The R33 phase does not have a budget limit but must reflect actual project needs. Applications requesting $500,000 or more in direct costs in any year of the R33 phase must notify a scientific/research contact at least six weeks before submission. Eligibility for this grant is broad, covering a range of U.S. and non-U.S. entities including higher education institutions, nonprofits, for-profits, tribal organizations, and local, state, and federal government entities. Applicants must complete registrations in systems like SAM, eRA Commons, and Grants.gov. Application submissions must follow strict guidelines in the SF424 (R&R) Application Guide, and use specified platforms like NIH ASSIST or Grants.gov Workspace. A letter of intent is recommended but not required. Applications are reviewed based on standard NIH criteria such as significance, innovation, approach, and environment. Special emphasis is placed on the clarity and feasibility of proposed milestones and the potential to impact the field of SUD research. Applications that fail to include required elements, especially milestones, will be deemed non-responsive. Submission deadlines align with NIH standard due dates and the expiration date for this opportunity is May 24, 2025. Contact information for scientific, financial, and submission-related questions is provided, with NIH encouraging potential applicants to reach out with inquiries.