HEAL Initiative: Planning Grants for Efficacy or Effectiveness Trials of Recovery Support Services for Individuals Treated with Medications for Opioid Use Disorder (R34 Clinical Trial Optional) | RFA DA 22 034

Opportunity Information: Apply for RFA DA 22 034

The HEAL Initiative funding opportunity "Planning Grants for Efficacy or Effectiveness Trials of Recovery Support Services for Individuals Treated with Medications for Opioid Use Disorder (R34 Clinical Trial Optional)" (RFA-DA-22-034) is a National Institutes of Health (NIH) discretionary grant designed to help applicants do the early-stage, practical work needed to launch a future full-scale clinical efficacy or effectiveness trial. Instead of funding a large definitive trial right away, this R34 mechanism supports pilot and preliminary research that strengthens the foundation for a rigorous study focused on people who currently take, or previously took, medications for opioid use disorder (MOUD). In other words, the goal is to move promising recovery support approaches closer to the level of evidence needed for confident clinical and real-world decision-making.

The program sits within the broader HEAL (Helping to End Addiction Long-term) Initiative and targets recovery support services that can improve outcomes for individuals treated with MOUD. NIH is signaling that, while MOUD is evidence-based and lifesaving, many additional supports that people rely on during and after treatment still lack strong efficacy or effectiveness evidence. The FOA therefore encourages applicants to generate the preliminary data, refine protocols, test feasibility, and solve implementation challenges so that a later, larger trial can be run credibly and efficiently. The "Clinical Trial Optional" labeling indicates that applicants may propose a clinical trial within the planning grant if it makes sense for their stage of development, but the central emphasis remains on planning and preparation activities rather than a definitive, fully powered test.

A major feature of this opportunity is the broad menu of recovery support services that can be proposed. The FOA explicitly includes, but is not limited to, peer-based recovery support, recovery community centers, active recovery communities, recovery residences, education-based recovery support services, and continuing care models. It also encourages services designed to meet the needs of specific minority health populations and specific health disparities populations, recognizing that recovery supports may need cultural tailoring, different delivery strategies, or different engagement approaches across communities. Applicants can also propose combinations of services or other recovery support models, as long as the rationale is clear and the work is aimed at positioning the field for a rigorous efficacy or effectiveness evaluation.

In practical terms, a planning grant under this announcement would typically support activities such as finalizing the intervention or service model, developing or adapting manuals and training, establishing partnerships with treatment programs or community-based providers, building referral and retention workflows for MOUD-treated participants, selecting outcomes and measurement strategies, and testing recruitment, randomization (if applicable), and follow-up procedures. It may also cover preliminary work on data systems, fidelity monitoring, staffing models, and acceptability to participants and providers. The end product NIH is looking for is a well-justified, trial-ready design: clear aims and hypotheses, a feasible study protocol, strong operational details, and pilot evidence that the future trial can be conducted with adequate enrollment, adherence, and data quality.

The opportunity is categorized under Education and Health activities and lists multiple CFDA numbers (93.213, 93.273, 93.279, 93.846, 93.866), reflecting NIH program and institute involvement tied to substance use, mental health, and related health research portfolios. The funding instrument is a grant, and the award ceiling is listed as $600,000. The original closing date in the source information is March 10, 2022, and the FOA was created December 29, 2021. While that date indicates this particular announcement may be historical, the content still reflects the type of planning-grant support NIH has used to accelerate evidence-building for recovery supports in MOUD populations.

Eligibility details in the source specify small businesses as eligible applicants, and the announcement also clarifies major restrictions related to foreign involvement. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by the NIH Grants Policy Statement are not allowed. These restrictions mean the work is expected to be led and conducted entirely within eligible U.S.-based organizations and settings, without foreign subcomponents.

Overall, this FOA is aimed at closing an evidence gap: many recovery support services are widely used, highly valued, and potentially impactful, but the field needs stronger, more rigorous testing specifically among people treated with MOUD. By funding the planning and pilot work that makes a later trial more credible and feasible, NIH is trying to speed the path from promising recovery supports to well-tested, scalable practices that improve retention in care, recovery stability, and longer-term health and functioning outcomes.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Planning Grants for Efficacy or Effectiveness Trials of Recovery Support Services for Individuals Treated with Medications for Opioid Use Disorder (R34 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, 93.846, 93.866.
• This funding opportunity was created on 2021-12-29.
• Applicants must submit their applications by 2022-03-10. (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 $600,000.00 in funding.
• Eligible applicants include: Small businesses.

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