Human Studies to Evaluate Promising Medications to Treat Alcohol Use Disorder (R03 Clinical Trial Required) | PA 18 198

Opportunity Information: Apply for PA 18 198

Human Studies to Evaluate Promising Medications to Treat Alcohol Use Disorder (R03 Clinical Trial Required) is an NIH grant opportunity (Funding Opportunity Number PA 18-198; CFDA 93.273) that supports small, early-stage human research projects focused on developing better medications for alcohol use disorder (AUD). The central purpose of the announcement is to push promising pharmacologic ideas into human testing, specifically by encouraging studies that can quickly generate initial evidence about whether a new or repurposed medication is safe and shows signs of benefit for people with AUD. A notable emphasis is placed on compounds that act on new biological targets, meaning applicants are expected to move beyond well-worn mechanisms and explore medications that bind to novel targets or engage pathways that are not yet established in AUD treatment. The opportunity also explicitly welcomes studies addressing AUD when it occurs alongside post-traumatic stress disorder (PTSD), reflecting the real-world overlap between these conditions and the need for treatments that work in more clinically complex populations.

The FOA requires human studies and is framed around two main types of research approaches. First, it supports human laboratory paradigms, which typically include controlled experimental methods that can measure medication effects on alcohol-related outcomes such as craving, alcohol self-administration, stress reactivity, cue reactivity, or other mechanistic and behavioral endpoints under standardized conditions. Second, it supports clinical trials, meaning prospective studies in people that evaluate a medication intervention with prespecified outcomes and systematic safety monitoring. In both cases, the intent is to generate credible, human-based evidence about safety and early efficacy rather than remaining at the preclinical or purely observational stage. Because this is an R03 mechanism, projects are generally expected to be tightly scoped, feasible, and efficient, producing a clear signal about whether a compound merits larger-scale testing later.

From a funding and administrative standpoint, this is a discretionary grant program administered by the National Institutes of Health. The listed award ceiling is $50,000, signaling that budgets should match the exploratory nature of the R03 and focus on high-impact, targeted experiments or small trials rather than large, multi-site efficacy studies. The posting indicates an original closing date of May 7, 2018, and a creation date of November 6, 2017, which is helpful for understanding the historical timeline of the announcement. Even when an FOA is older, the structure and priorities described here are typical of NIH exploratory clinical trial opportunities in substance use treatment development: they are designed to de-risk ideas by producing early human data that can justify subsequent, larger applications.

Eligibility is broad and includes many organization types that might contribute meaningfully to AUD medication development. Eligible applicants include state, county, city, or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories such as 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, U.S. territories or possessions, eligible federal agencies, and even non-U.S. (foreign) entities. That breadth suggests NIH is seeking to draw from a wide research ecosystem, including community-rooted organizations and institutions serving populations that are often underrepresented in clinical research, which can be especially relevant in AUD and comorbid PTSD where access, cultural context, and differential treatment response may matter.

Overall, the opportunity is aimed at accelerating the medication development pipeline for AUD by funding carefully designed, human-focused studies that can provide early evidence of safety and potential effectiveness for novel or repurposed compounds acting on new targets. Applicants are expected to propose rigorous, ethical, and clinically meaningful experiments or trials that can move a candidate medication closer to real-world use, including for individuals facing the added complexity of co-occurring PTSD.

• 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 (R03 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 $50,000.00 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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