HEAL Initiative: Developing an Evidence Base for Co-Occurring OUD-AUD Interventions (R01 Clinical Trial Optional) | RFA AA 23 005

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The HEAL Initiative funding opportunity titled "Developing an Evidence Base for Co-Occurring OUD-AUD Interventions (R01 Clinical Trial Optional)" (RFA-AA-23-005) is an NIH grant program aimed at building stronger, practical evidence for how to treat people who simultaneously have Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD). The central problem the NOFO is trying to address is that alcohol use meaningfully increases the risk of fatal opioid overdose, yet real-world treatment systems often do not have clear, evidence-based guidance for managing both disorders together. Because of that uncertainty, some clinicians may under-prescribe or hesitate to provide opioid agonist therapies (OATs) like methadone or buprenorphine to patients who also have AUD or who are misusing alcohol, even though these medications are key tools for reducing opioid-related harms.

A major theme of the announcement is that co-occurring OUD and AUD creates a complicated, two-way clinical dynamic that standard OUD-only research and care models do not always capture. The NOFO notes observations that opioid and alcohol use can be reciprocal in this population: when opioid intake decreases, some patients may increase drinking, which in turn can raise the risk of opioid relapse and overdose. That pattern points to a need for targeted, integrated approaches that account for both substances at once, rather than treating alcohol use as a secondary issue or excluding it from study designs. The NOFO also highlights that, while many OUD studies do not explicitly exclude people who drink, they often fail to intentionally recruit participants with diagnosable AUD, leaving major evidence gaps about outcomes and best practices for the people at highest combined risk.

In terms of what NIH wants applicants to do, the NOFO supports two broad types of work. First, it encourages secondary analyses of existing data drawn from relevant clinical studies, completed projects, or established archives, with the goal of extracting clearer answers about how people with co-occurring OUD-AUD are currently being treated and what outcomes are associated with different treatment patterns. Second, it supports new hypothesis-clarifying studies designed to sharpen understanding of real-world treatment challenges, identify which interventions appear safest and most effective for this specific population, and help shape best-practice recommendations. The scope explicitly includes medication-assisted approaches, psychosocial interventions, and complementary interventions, reflecting an interest in both pharmacologic and non-pharmacologic strategies, especially given the stated lack of research on non-pharmacological therapies for people with OUD-AUD.

The mechanism is an R01, with clinical trials listed as optional, meaning applicants can propose projects that do or do not involve a clinical trial depending on the research question and design. The opportunity is part of NIH and the broader HEAL Initiative, aligning it with federal efforts to reduce overdose deaths and improve evidence-based care for substance use disorders. The listed award ceiling is $250,000, and the original closing date shown is 2023-12-14.

Eligibility is broad and includes many common applicant types such as state, county, and local governments; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and Native American tribal governments and organizations. The NOFO also calls out additional eligible applicants and settings, including faith-based and community-based organizations, historically underrepresented and mission-driven institutions (such as HBCUs, Hispanic-serving institutions, Tribal Colleges and Universities, and AANAPISI institutions), eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). Overall, the program is designed to bring more rigorous, actionable evidence to a clinical area where risk is high, practice is inconsistent, and the usual single-disorder research approach has left important questions unanswered for people living with both OUD and AUD.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Developing an Evidence Base for Co-Occurring OUD-AUD Interventions (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.273, 93.279, 93.866.
• This funding opportunity was created on 2023-09-11.
• Applicants must submit their applications by 2023-12-14. (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 $250,000.00 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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