HEAL Initiative: Oral Complications Arising from Pharmacotherapies to Treat Opioid Use Disorders (R01 Clinical Trial Not Allowed) | RFA DE 23 015

Opportunity Information: Apply for RFA DE 23 015

The grant opportunity titled "HEAL Initiative: Oral Complications Arising from Pharmacotherapies to Treat Opioid Use Disorders (R01 Clinical Trial Not Allowed)" is a National Institutes of Health (NIH) research funding announcement designed to deepen scientific understanding of oral and dental problems linked to medications used to treat opioid use disorder (OUD). It sits under the broader HEAL (Helping to End Addiction Long-term) Initiative, which supports research aimed at reducing opioid misuse and improving outcomes for people affected by addiction. This particular funding call focuses on the oral health side of the equation, specifically the biological mechanisms and real-world patterns of oral complications that may arise in people receiving OUD pharmacotherapies, and how those complications develop and change over time.

At the core of the FOA is an interest in the biology, natural history, and directionality of oral complications associated with OUD medications. In practical terms, NIH is looking for studies that can clarify what oral conditions occur, when they tend to appear, whether they worsen or improve, and how strongly they can be attributed to pharmacotherapy itself versus other factors common in OUD-affected populations. The emphasis on "directionality" signals that the agency wants work that can sort out cause-and-effect pathways: for example, whether a medication contributes to changes in saliva, oral microbiology, inflammation, immune response, diet, hygiene practices, or other physiological and behavioral factors that then accelerate caries, periodontal disease, mucosal problems, infections, or tooth loss. The announcement also leaves room for research that distinguishes medication-related effects from the impacts of co-occurring conditions, polysubstance use, tobacco use, nutrition insecurity, and barriers to routine dental care.

A second major aim is to support research on access-to-care challenges and other real-world barriers that may drive the onset and progression of dental and oral disease among people with OUD. That means the FOA is not only about laboratory or mechanistic work; it also encourages health services and implementation-oriented research that examines why oral disease is so common and so often untreated in this population. Topics that fit this intent include structural and logistical barriers to obtaining dental care, fragmentation between medical/OUD treatment settings and dental systems, stigma and discrimination, insurance limitations, geographic shortages of dental providers, and the practical difficulties of attending appointments during recovery. The long-term purpose is to generate evidence that can lead to targeted prevention strategies, meaning approaches tailored to the needs and risk profile of individuals receiving OUD pharmacotherapies rather than generic oral health advice.

This is an R01 grant mechanism, which is NIH's standard research project grant and is typically used for substantial, multi-year research programs with clear aims, rigorous methods, and meaningful impact potential. The FOA explicitly states "Clinical Trial Not Allowed," which means applicants must propose studies that do not meet NIH's definition of a clinical trial (for example, not prospectively assigning human participants to an intervention to evaluate a health-related outcome). Applicants can still often include human subjects research, observational studies, analyses of existing clinical data, cohort studies, or mechanistic studies that do not involve assigning participants to interventions, but they must stay within the "no clinical trial" boundary.

Eligibility is broad and includes a wide range of U.S.-based organizations and governmental entities. Eligible applicants include state, county, and city 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in that category); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, the announcement makes clear that foreign organizations and foreign institutions are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed. In short, the work must be led and carried out without foreign components under NIH definitions.

From an administrative standpoint, the funding opportunity number is RFA-DE-23-015, and the sponsoring agency is NIH. The opportunity is categorized as a discretionary grant funding instrument, and it is associated with CFDA numbers 93.121, 93.213, and 93.279, which reflect the federal assistance listings tied to NIH and related health research programs. The original closing date listed for applications was February 14, 2023, and the posting creation date was August 3, 2022. The publicly provided fields do not specify an award ceiling or the expected number of awards in the excerpt, so applicants would typically need to consult the full FOA text for budget expectations, project period limits, review criteria emphasis, and any institute-specific priorities.

Overall, this FOA is aimed at building a stronger evidence base around how OUD treatment medications intersect with oral health, why oral disease burden remains high in this population, and what kinds of prevention strategies could realistically reduce harm. The NIH is signaling a desire for research that connects biological mechanisms with lived realities of care access, with the end goal of practical, targeted prevention approaches that can be integrated into the broader treatment and recovery landscape for people with opioid use disorder.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Oral Complications Arising from Pharmacotherapies to Treat Opioid Use Disorders (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.213, 93.279.
• This funding opportunity was created on 2022-08-03.
• Applicants must submit their applications by 2023-02-14. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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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