Human Studies to Evaluate Promising Medications to Treat Alcohol Use Disorder (R21 Clinical Trial Required) | PA 18 197

Opportunity Information: Apply for PA 18 197

The Human Studies to Evaluate Promising Medications to Treat Alcohol Use Disorder (R21 Clinical Trial Required) opportunity (PA 18-197) is a National Institutes of Health (NIH) discretionary grant focused on accelerating early-stage human research on medications for alcohol use disorder (AUD). The main goal is to support studies that move beyond basic or preclinical work and directly test promising pharmacologic approaches in people, using either controlled human laboratory paradigms and/or clinical trials. The emphasis is on evaluating both safety and efficacy signals for novel compounds or repurposed medications, especially those that act on new biological targets rather than simply re-testing well-worn mechanisms. In addition to AUD alone, the announcement specifically highlights interest in treatments for AUD that occurs alongside comorbid post-traumatic stress disorder (PTSD), reflecting the clinical reality that co-occurring conditions can complicate treatment and may require targeted medication strategies.

This FOA uses the NIH R21 mechanism, which is typically intended for exploratory or developmental projects that can generate strong preliminary evidence, proof-of-concept findings, or key feasibility and safety data to justify larger follow-on trials. The listing indicates an award ceiling of $200,000, positioning these awards as smaller, early-phase investments designed to de-risk innovative ideas rather than fund large, definitive efficacy trials. The activity category is Health, and the associated CFDA number is 93.273, which corresponds to NIH programs in this area. Because the opportunity is labeled "Clinical Trial Required," applicants are expected to include a clinical trial component or a clearly trial-like human experimental design that meets NIH’s definition of a clinical trial, rather than purely observational or non-interventional human research.

The types of studies encouraged include carefully designed human laboratory paradigms (for example, experimental medicine approaches that can probe alcohol craving, stress reactivity, cue-induced responses, or alcohol self-administration under controlled conditions) as well as clinical trial designs that can test medication effects in real-world or semi-controlled settings. The core expectation is that the project will evaluate a medication candidate in humans and produce interpretable data on safety and potential benefit for AUD outcomes, and potentially for PTSD-related outcomes when the comorbidity is included. The mention of "new targets" signals that NIH is looking for innovation in mechanism of action, such as compounds that modulate neurobiological systems not yet widely leveraged in current AUD pharmacotherapy, and repurposed medications are acceptable when they provide a credible rationale for engaging a novel or underexplored target relevant to AUD or AUD+PTSD.

Eligibility is broad and designed to bring in a wide range of research-capable organizations. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized); tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education when relevant); for-profit organizations (other than small businesses); small businesses; and other entities. The announcement also calls out additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, non-domestic (non-U.S.) entities (foreign organizations), and U.S. territories or possessions. This wide eligibility list reflects an intent to encourage participation from diverse institutional settings and communities, including those disproportionately affected by AUD and those positioned to recruit specialized populations.

Key administrative details included in the source data indicate the opportunity was created on 2017-11-06 and lists an original closing date of 2018-05-07. The funding instrument type is a grant, and the opportunity category is discretionary, consistent with NIH’s competitive research funding model. While the summary data does not specify the number of expected awards, the presence of a ceiling amount and the R21 mechanism together imply a limited-scope, high-impact exploratory funding approach intended to seed innovative medication-testing studies and generate data that can inform later, larger trials and broader treatment development efforts.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Human Studies to Evaluate Promising Medications to Treat Alcohol Use Disorder (R21 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273.
• This funding opportunity was created on 2017-11-06.
• Applicants must submit their applications by 2018-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $200,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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