The National Institute on Alcohol Abuse and Alcoholism (NIAAA) under the National Institutes of Health (NIH) is soliciting applications for the R34 Clinical Trial Required mechanism, focused on alcohol treatment and recovery research. This funding opportunity supports research aimed at advancing treatment and recovery strategies for Alcohol Use Disorder (AUD), including medications development, precision medicine, behavioral therapies, mechanisms of behavioral change, recovery trajectories, translational research, and innovative technologies. The grant is intended to facilitate the planning and preparation necessary for implementing larger-scale clinical trials. Projects may include the establishment of research teams, development of trial designs, creation of operational manuals, and pilot studies to assess feasibility. However, preliminary data collection or pilot studies aimed at supporting the rationale for a clinical trial are excluded.

The purpose of this funding opportunity is to build foundational knowledge that will enhance treatment methods and strategies for preventing alcohol-related health problems. Research areas of focus include developing and testing experimental medications, integrating behavioral therapies with medications, understanding recovery mechanisms, and leveraging innovative technologies such as mobile health tools and digital interventions. The NIAAA places emphasis on populations that are often underserved or face health disparities, including individuals with psychiatric comorbidities, women, adolescents, young adults, older adults, and military personnel. The initiative also seeks to address disparities in access to AUD treatments, improve care models, and identify cultural and socioeconomic factors that influence recovery outcomes.

Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, tribal governments, and foreign entities. Institutions serving historically underrepresented populations, such as Historically Black Colleges and Universities (HBCUs) and Hispanic-serving Institutions, are encouraged to apply. All applicants must complete registrations in multiple systems, including SAM, Grants.gov, and eRA Commons, before submission. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, women, and individuals with disabilities, are encouraged to apply.

Applications must include a detailed research plan adhering to NIH application guidelines. Key submission components include a letter of intent submitted 30 days prior to the application due date, human subjects protections plans, and adherence to the NIH Data Management and Sharing Policy. Proposals must address scientific rigor, inclusion of diverse populations, and sound data analysis plans. Applications must be submitted electronically via Grants.gov, NIH ASSIST, or institutional system-to-system solutions.

Evaluation of applications will consider the importance of the research, the rigor and feasibility of the proposed approach, and the expertise and resources of the investigative team. Specific review criteria include the significance and innovation of the research, the robustness of the methodology, and the qualifications of the investigators. Additional considerations will include protections for human subjects, data safety and monitoring plans, and the inclusion of underrepresented populations in clinical research.

The funding opportunity supports direct costs of up to $450,000 over a three-year period, with no more than $225,000 allowed in a single year. Standard NIH application due dates apply, with the earliest submission date being January 16, 2025, and the expiration date set for September 8, 2026. Award decisions will depend on scientific merit, availability of funds, and alignment with NIAAA program priorities. Prospective applicants are encouraged to contact designated program officials for guidance and submit applications well before the deadlines to allow time for corrections.