Opportunity Information: Apply for PA 15 254
Apply for PA 15 254
- 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)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273 Alcohol Research Programs.
- This funding opportunity was created on May 13, 2015 and posted on May 13, 2015.
- Applicants must submit their applications by May 7, 2018. (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: Others (see text field entitled Additional Information on Eligibility for clarification) County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Special district governments State governments Small businesses For profit organizations other than small businesses City or township governments Public housing authorities/Indian housing authorities Independent school districts Native American tribal governments (Federally recognized) Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
This NIH grant opportunity, titled "Human Studies to Evaluate Promising Medications to Treat Alcohol Use Disorder (R21)" (Funding Opportunity Number PA-15-254), supported early-stage, exploratory research aimed at identifying and testing medications for alcohol use disorder (AUD). The central goal was to stimulate applications that move beyond basic discovery and into human research, using either controlled human laboratory paradigms and/or clinical trials to evaluate both safety and efficacy. A key emphasis was on testing novel compounds or repurposed medications that act on new biological targets, meaning the program was looking for therapeutics with mechanisms not already well covered by existing AUD treatments. In addition to AUD alone, the FOA specifically encouraged work addressing AUD when it co-occurs with post-traumatic stress disorder (PTSD), recognizing that comorbidity can complicate treatment response and clinical outcomes and may require tailored pharmacologic approaches.
The award mechanism was the NIH R21, which is generally designed for exploratory and developmental projects that generate preliminary data, establish feasibility, and de-risk innovative ideas that may later scale into larger trials or R01-level programs. While the FOA description highlights both human laboratory studies and clinical trials, the spirit of the opportunity was to support promising, high-impact medication leads at a stage where human testing could clarify whether a candidate is safe, tolerable, and potentially effective, and whether the study approach is workable for larger confirmatory investigations. The program’s interest in "human laboratory paradigms" signals support for tightly controlled experimental designs often used in addiction research, such as paradigms that measure craving, stress reactivity, cue-induced responses, alcohol self-administration behavior under controlled conditions, or other translational endpoints that can show early signs of medication effect before committing to larger and more expensive trials.
Administratively, this was a discretionary grant program under the National Institutes of Health, categorized within health research and tied to CFDA number 93.273 (Alcohol Research Programs). Cost sharing or matching was not required, which typically lowers the barrier to entry for academic, nonprofit, and smaller organizational applicants. The maximum award ceiling listed for the opportunity was $200,000, consistent with the smaller-scale, exploratory intent of an R21. The announcement was posted May 13, 2015, with an original and final closing date of May 7, 2018, and it was archived June 7, 2018, meaning it is no longer open for new submissions under that specific announcement version.
Eligibility was broad and included a wide range of U.S. organizations and governmental units, reflecting NIH’s standard openness to diverse research performers. Eligible applicants included federal, state, local, and tribal government entities; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; small businesses; and for-profit organizations that are not small businesses. The opportunity also explicitly included a variety of mission-driven and capacity-building institution types and communities, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and Asian American, Native American, and Pacific Islander-serving institutions (AANAPISIs), along with faith-based and community-based organizations. Importantly, the FOA also allowed non-U.S. entities (foreign organizations) and regional organizations, as well as U.S. territories or possessions, which broadens participation for international collaboration or research that benefits from specialized populations or facilities.
In practical terms, an application responding to this FOA would be expected to propose a clear medication candidate (new or repurposed) with a rationale for its target and relevance to AUD biology and behavior, then pair that candidate with an appropriate human study design to test safety signals and early efficacy markers. For comorbid AUD and PTSD, the project would likely need to articulate why that subgroup is clinically important, how the medication might influence overlapping mechanisms such as stress circuitry, arousal, negative affect, or trauma-related symptom triggers, and how the study will measure outcomes that are meaningful to both conditions. Overall, the opportunity was structured to accelerate the translation of promising pharmacologic ideas into human evidence, with the intention of identifying which candidates and targets deserve larger clinical investment.
For full archival details, NIH provided the announcement link (http://grants.nih.gov/grants/guide/pa-files/PA-15-254.html). For access or technical issues related to the online announcement, the listed contact was the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@od.nih.gov.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this NIH grant?
The opportunity is titled "Human Studies to Evaluate Promising Medications to Treat Alcohol Use Disorder (R21)" and the Funding Opportunity Number (FOA) is PA-15-254.
What is the main goal of this funding opportunity?
The central goal was to stimulate early-stage, exploratory applications that move beyond basic discovery into human research to identify and test medications for alcohol use disorder (AUD), using human laboratory paradigms and/or clinical trials to evaluate safety and efficacy.
What type of research was this FOA trying to support?
This FOA supported human studies that evaluate promising medication candidates for AUD, including tightly controlled human laboratory studies and clinical trials designed to generate early evidence about safety, tolerability, and potential effectiveness.
What does the NIH R21 mechanism mean in the context of this opportunity?
The award mechanism was the NIH R21, which is generally intended for exploratory and developmental projects. In this context, it was meant to help applicants generate preliminary data, demonstrate feasibility, and reduce risk for innovative medication ideas that could later justify larger trials or R01-level programs.
What kinds of study designs were encouraged?
The FOA highlighted both controlled human laboratory paradigms and clinical trials. The human laboratory emphasis indicates support for tightly controlled experimental designs that can provide early signals of medication effects before larger, more expensive confirmatory trials.
What are examples of "human laboratory paradigms" mentioned or implied by the FOA?
The FOA referenced paradigms commonly used in addiction research, such as studies measuring craving, stress reactivity, cue-induced responses, alcohol self-administration under controlled conditions, and other translational endpoints intended to detect early medication effects.
Was the program interested only in discovering new medications?
No. The FOA emphasized testing novel compounds and repurposed medications, particularly those that act on new biological targets relevant to AUD.
What does "new biological targets" mean here?
It means the program was looking for therapeutics with mechanisms of action not already well covered by existing AUD treatments, with the aim of expanding and diversifying medication approaches for AUD.
Did the FOA include alcohol use disorder with co-occurring conditions?
Yes. In addition to AUD alone, the FOA specifically encouraged work addressing AUD when it co-occurs with post-traumatic stress disorder (PTSD).
Why did the FOA emphasize AUD and PTSD comorbidity?
The FOA recognized that comorbidity can complicate treatment response and clinical outcomes and may require tailored pharmacologic approaches, especially where overlapping mechanisms such as stress circuitry, arousal, negative affect, or trauma-related triggers may influence outcomes.
What would an application generally be expected to include?
Based on the description, an application would be expected to (1) propose a clear medication candidate (new or repurposed), (2) provide a rationale for the biological target and its relevance to AUD, and (3) include an appropriate human study design to evaluate safety signals and early efficacy markers. For AUD with PTSD, the application would also be expected to justify the subgroup and specify meaningful outcomes for both conditions.
Was cost sharing or matching required?
No. Cost sharing or matching was not required.
What was the maximum award amount listed for this opportunity?
The maximum award ceiling listed was $200,000, consistent with the exploratory intent of an R21.
Which NIH program area or CFDA number was associated with this FOA?
The opportunity was tied to CFDA number 93.273 (Alcohol Research Programs).
Who was eligible to apply?
Eligibility was broad and included federal, state, local, and tribal government entities; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); small businesses; and for-profit organizations that are not small businesses.
Did the FOA explicitly welcome applications from specific institution types or communities?
Yes. It explicitly included a range of mission-driven and capacity-building institution types and communities, including HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, AANAPISIs, and faith-based and community-based organizations.
Were non-U.S. or foreign organizations eligible?
Yes. The FOA allowed non-U.S. entities (foreign organizations) and regional organizations, as well as U.S. territories or possessions.
When was this funding opportunity posted?
The announcement was posted on May 13, 2015.
What were the original and final closing dates?
The FOA listed an original and final closing date of May 7, 2018.
Is this FOA still open for new submissions?
No. It was archived on June 7, 2018, which indicates it is no longer open for new submissions under that specific announcement version.
Where can I find the archived NIH announcement?
The archived announcement link provided is: http://grants.nih.gov/grants/guide/pa-files/PA-15-254.html
Who should be contacted for access or technical issues with the online announcement?
For access or technical issues related to the online announcement, the listed contact was the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@od.nih.gov.
What was the overall intent of the program?
Overall, the opportunity was structured to accelerate translation of promising pharmacologic ideas into human evidence, helping identify which medication candidates and biological targets merit larger clinical investment.
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