Opportunity Information: Apply for PA 15 256

  • 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 (R01)" 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.)
  • Eligible applicants include: State governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Small businesses County governments Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Private institutions of higher education Native American tribal governments (Federally recognized).
  • 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:

The grant opportunity titled "Human Studies to Evaluate Promising Medications to Treat Alcohol Use Disorder (R01)" (Funding Opportunity Number PA 15-256) is a National Institutes of Health (NIH) research grant announcement aimed at accelerating the development of new medication options for alcohol use disorder (AUD). The core purpose of the program is to support human-subject research that tests whether promising medications are safe and effective for treating AUD, including cases where AUD occurs alongside comorbid post-traumatic stress disorder (PTSD). In practical terms, NIH is looking for studies that move beyond basic discovery and into well-designed human laboratory studies and/or clinical trials that can produce actionable evidence about therapeutic potential.

A key emphasis of the announcement is on evaluating novel or repurposed compounds that act on new biological targets. This focus signals an interest in expanding treatment strategies beyond currently available AUD medications by exploring drugs with mechanisms that have not been fully leveraged in AUD care. "Repurposed" compounds refers to medications that may already exist for other conditions but are being tested here for AUD or AUD with PTSD, while "novel" compounds suggests new therapeutic candidates that have not yet been tried in this context. The requirement that compounds "bind to new targets" underscores the intention to diversify the pharmacological toolbox for AUD by investigating mechanisms that could better address craving, reinforcement, stress responsivity, relapse risk, or other clinically meaningful outcomes.

The announcement uses the R01 mechanism, which is NIH's standard Research Project Grant. This typically supports substantial, hypothesis-driven projects with clear aims, rigorous methodology, and enough scope to generate definitive findings. Consistent with that mechanism, applications are expected to propose strong study designs, whether that involves controlled human laboratory paradigms (for example, experimental models that can measure alcohol craving, stress-induced drinking motivation, cue reactivity, or alcohol self-administration under standardized conditions) and/or clinical trials (which could include early-stage safety assessments through to efficacy-oriented testing). The unifying theme is that the work must involve human participants and produce evidence relevant to medication development for AUD or AUD with comorbid PTSD.

From an administrative standpoint, this is a discretionary grant opportunity in the health funding category, listed under CFDA number 93.273 (Alcohol Research Programs). There is no cost-sharing or matching requirement, meaning applicants are not required to provide non-federal matching funds as a condition of the award. The opportunity was posted and created on May 13, 2015, with an original and final closing date of May 7, 2018, and it was archived on June 7, 2018. While archived opportunities are no longer open for new submissions, the summary still matters for understanding NIH priorities at the time and for locating related or successor announcements.

Eligibility is broad and includes a wide range of public and private entities. Eligible applicants include state, county, city/township, and special district governments; public and private institutions of higher education; public and state-controlled universities; independent school districts; and public housing authorities/Indian housing authorities. The FOA also allows participation from nonprofit organizations both with and without 501(c)(3) status (excluding institutions of higher education in those categories), as well as for-profit organizations other than small businesses, and small businesses themselves. It explicitly expands eligibility to various mission-focused institutions and organizations, including 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 Pacific Islander Serving Institutions (AANAPISIs). Faith-based and community-based organizations are included, and notably, non-domestic (non-U.S.) entities (foreign organizations), regional organizations, U.S. territories or possessions, and eligible federal agencies are also listed as eligible, which reflects NIH's openness to high-quality, globally relevant research collaborations when appropriate.

For applicants or institutions needing more information, the primary reference point is the full FOA text hosted on the NIH grants site (link provided in the source data). For access or technical issues, NIH directs inquiries to the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV, particularly for problems accessing or linking to the announcement online.

Overall, this FOA is best understood as an NIH effort to strengthen the medication development pipeline for AUD by funding rigorous human studies that test innovative pharmacological approaches, including treatments tailored to the clinically challenging subgroup of individuals with both AUD and PTSD. The central deliverable NIH is seeking is credible human evidence, generated through laboratory paradigms and/or clinical trials, that can clarify whether a candidate compound is both safe and meaningfully beneficial for these populations.

Frequently Asked Questions (FAQs)

What is the official title and funding opportunity number for this grant?

The opportunity is titled "Human Studies to Evaluate Promising Medications to Treat Alcohol Use Disorder (R01)" and the Funding Opportunity Number is PA 15-256.

Which federal agency is offering this funding opportunity?

This is a National Institutes of Health (NIH) research grant announcement.

What is the main purpose of this FOA?

The purpose is to accelerate the development of new medication options for alcohol use disorder (AUD) by supporting human-subject research that tests whether promising medications are safe and effective for treating AUD, including AUD with comorbid post-traumatic stress disorder (PTSD).

What kinds of studies does this FOA support?

The FOA supports human-subject research that moves beyond basic discovery and into well-designed human laboratory studies and/or clinical trials that can produce actionable evidence about therapeutic potential for AUD or AUD with PTSD.

Does the research have to involve human participants?

Yes. The unifying theme is that the proposed work must involve human participants and produce evidence relevant to medication development for AUD or AUD with comorbid PTSD.

What is the grant mechanism used in this announcement?

The FOA uses the R01 mechanism, NIH's standard Research Project Grant, which typically supports substantial, hypothesis-driven projects with clear aims and rigorous methodology.

What is NIH especially interested in testing under this program?

NIH emphasizes evaluating novel or repurposed compounds that act on new biological targets, with the goal of expanding treatment strategies beyond currently available AUD medications.

What does "repurposed" mean in the context of this FOA?

"Repurposed" refers to medications that may already exist for other conditions but are being tested here for AUD or AUD with comorbid PTSD.

What does "novel" mean in the context of this FOA?

"Novel" refers to new therapeutic candidates that have not yet been tried in this context (AUD or AUD with PTSD) as described in the FOA summary.

What does it mean that compounds should "bind to new targets"?

It indicates an interest in medications that act on biological mechanisms that have not been fully leveraged in AUD care, with the intent to diversify treatment approaches and explore mechanisms relevant to craving, reinforcement, stress responsivity, relapse risk, or other clinically meaningful outcomes.

Are studies involving AUD with comorbid PTSD within scope?

Yes. The FOA explicitly includes evaluation of medications for AUD, including cases where AUD occurs alongside comorbid PTSD.

What types of human laboratory approaches are mentioned as examples?

Examples include controlled experimental models that can measure alcohol craving, stress-induced drinking motivation, cue reactivity, or alcohol self-administration under standardized conditions.

What types of clinical trials are within scope?

The FOA indicates clinical trials could range from early-stage safety assessments through to efficacy-oriented testing, as long as the work produces evidence relevant to medication development for AUD or AUD with PTSD.

What funding category and assistance listing are associated with this opportunity?

It is listed in the health funding category and is associated with CFDA number 93.273 (Alcohol Research Programs).

Is cost-sharing or matching required?

No. The opportunity states there is no cost-sharing or matching requirement.

When was this opportunity posted, and what were the closing dates?

The opportunity was posted/created on May 13, 2015. The original closing date and final closing date were May 7, 2018.

Is this funding opportunity still open?

No. It was archived on June 7, 2018, and archived opportunities are no longer open for new submissions.

Why might this archived FOA still be useful?

Even though it is no longer open, the summary can still be useful for understanding NIH priorities at the time and for locating related or successor announcements.

Who is eligible to apply?

Eligibility is broad and includes many public and private entities, including governments, eligible educational institutions, nonprofits, for-profits, small businesses, and certain non-U.S. and federal entities, as listed in the FOA summary.

Which government entities are eligible?

Eligible government applicants include state governments; county governments; city or township governments; and special district governments.

Are educational institutions eligible?

Yes. Eligible applicants include public and private institutions of higher education, public and state-controlled institutions of higher education, universities, and independent school districts.

Are nonprofits eligible, and do they need 501(c)(3) status?

Yes. Nonprofit organizations with or without 501(c)(3) status are eligible (excluding institutions of higher education in those nonprofit categories, as stated in the summary).

Are for-profit organizations eligible?

Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also eligible.

Are faith-based and community-based organizations eligible?

Yes. Faith-based and community-based organizations are included as eligible applicants.

Are mission-focused and minority-serving institutions included in eligibility?

Yes. The eligibility list explicitly includes 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 Pacific Islander Serving Institutions (AANAPISIs).

Are non-U.S. organizations eligible to apply?

Yes. The summary states that non-domestic (non-U.S.) entities (foreign organizations) and regional organizations are eligible, and it also lists U.S. territories or possessions.

Are federal agencies eligible applicants?

Yes. Eligible federal agencies are listed as eligible applicants in the summary.

Where can applicants find the full FOA text?

The full FOA text is hosted on the NIH grants site (the link is referenced in the source data described in the summary).

Who should be contacted for technical problems accessing or linking to the announcement online?

NIH directs access or technical issue inquiries to the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.

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