Alcohol Treatment, Pharmacotherapy, and Recovery Research (R01 Clinical Trial Required)

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is soliciting applications for the Alcohol Treatment, Pharmacotherapy, and Recovery Research grant under the R01 Clinical Trial Required mechanism. This funding opportunity aims to support clinical research on topics related to the treatment of and recovery from Alcohol Use Disorder (AUD). The primary focus areas include the development and evaluation of medications, behavioral therapies, mechanisms of behavioral change (MOBC), recovery processes, translational research, and innovative technologies for AUD treatment and recovery. Research priorities also address health disparities, age, sex/gender, racial and ethnic differences, co-occurring psychiatric disorders, and unique challenges faced by military populations. Key research objectives include evaluating experimental and repurposed medications, integrating treatment approaches for AUD and psychiatric comorbidities, and exploring behavioral therapies that address treatment heterogeneity and key mechanisms of change. Research into the neurobiological, psychological, environmental, and social factors influencing AUD recovery is also emphasized. Additionally, studies examining innovative technologies such as mobile health applications, telemedicine, and real-time data collection tools are encouraged. Projects focusing on health disparities aim to address barriers to treatment access, including social determinants of health, cultural beliefs, and healthcare literacy. Specific populations of interest include women, adolescents, young adults, older adults, and individuals with psychiatric comorbidities. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state and local governments, tribal entities, independent school districts, public housing authorities, faith-based organizations, regional organizations, and foreign entities. Institutions serving underrepresented communities, such as Historically Black Colleges and Universities (HBCUs) and Hispanic-serving Institutions, are also encouraged to apply. Applicants must complete registrations with SAM, Grants.gov, and eRA Commons before submission. Individuals with diverse backgrounds, including those from underrepresented racial and ethnic groups, women, and individuals with disabilities, are strongly encouraged to participate. Applicants must submit a letter of intent at least 30 days before the application due date. The application must follow NIH guidelines, including the submission of a detailed research plan, a Data Management and Sharing Plan, and consideration of human subject protections. Applications proposing projects exceeding $500,000 in direct costs per year require prior approval at least six weeks before submission. Studies must be conducted exclusively on human subjects, and projects focusing on animal studies, HIV/AIDS research, substance use disorders involving drugs other than alcohol, or prevention-focused clinical trials will not be considered responsive. Applications will be reviewed based on scientific merit, feasibility, innovation, investigator expertise, and alignment with NIAAA’s research priorities. Review criteria will focus on the significance of the proposed research, the rigor of the scientific approach, and the capability of the research team and institutional resources. Additional considerations include the adequacy of plans for human subject protections, data sharing, and inclusion of diverse populations. Projects must demonstrate the potential to advance AUD treatment, improve recovery outcomes, and address barriers to care. The maximum project period is five years, with a direct cost limit of $500,000 per year unless prior approval is obtained. Applications will follow standard NIH due dates, with the earliest submission date being January 5, 2025, and the final expiration date set for September 8, 2026. All applications must be submitted electronically through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. Prospective applicants are encouraged to contact NIAAA program officials for guidance early in the application process. Successful proposals are expected to contribute significantly to the understanding and treatment of AUD, addressing both scientific gaps and practical barriers to effective care.