HEAL Initiative: Pilot and Feasibility Trials to Improve Prevention and Treatment Service Delivery for Polysubstance Use (R34 Clinical Trial Optional) | RFA DA 22 048

Opportunity Information: Apply for RFA DA 22 048

This funding opportunity is an NIH grant under the HEAL (Helping to End Addiction Long-term) Initiative that supports early-stage, pilot, and feasibility research aimed at improving how prevention and treatment services are delivered for people affected by polysubstance use (use of more than one substance, such as opioids combined with stimulants, alcohol, benzodiazepines, or other drugs). It uses the R34 mechanism, which is designed to help investigators generate the preliminary evidence, practical workflows, and real-world implementation knowledge needed before launching larger, more definitive services research effectiveness trials. Clinical trials are optional, meaning an application can include a small pilot trial if it fits the aims, but it can also focus on preparatory work that strengthens a later full-scale trial.

The core purpose is to move the field toward personalized and tailored service approaches that better match prevention and treatment to an individuals needs, risks, and contexts, especially when multiple substances are involved. The FOA emphasizes research that sets the stage for future, larger clinical or services trials, including developmental activities like refining or adapting service delivery models, designing and testing components of complex service bundles, establishing feasibility and acceptability in real settings, and identifying what it would take to implement and sustain these approaches in routine care. A key theme is service delivery, not just whether an intervention works in theory, but how it can actually be delivered effectively across systems such as clinics, community programs, health systems, justice settings, or other care environments.

Projects of interest can include work on implementation approaches that support the delivery of complex bundles of services, for example combining screening and risk stratification, linkage to medications for opioid use disorder, contingency management for stimulant use, behavioral therapies, harm reduction supports, care coordination, telehealth elements, peer navigation, and referral pathways for co-occurring mental and physical health needs. Because polysubstance use often involves overlapping risks and comorbidities, the FOA is oriented toward practical research that clarifies how to tailor intensity, sequence, and combinations of services and how to integrate them into existing systems without overburdening staff or patients. The intended output is a strong foundation for a later, fully powered services effectiveness trial, including clearer intervention definitions, workable protocols, implementation strategies, recruitment and retention plans, and credible preliminary signals that the approach can be delivered and evaluated.

Administratively, this is a discretionary grant opportunity from the National Institutes of Health with Funding Opportunity Number RFA-DA-22-048. It falls under health and education-related funding activity categories and is associated with CFDA numbers 93.213, 93.273, 93.279, 93.846, and 93.866. The original closing date listed for this specific announcement was 2022-03-10, and the award ceiling shown is $225,000 (as presented in the source data). The FOA was created on 2021-12-29.

Eligibility is broad and includes many types of domestic organizations and government entities. Eligible applicants include state, county, and city or township 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 other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, Hispanic-serving institutions, historically Black colleges and universities (HBCUs), Indian/Native American tribal governments other than federally recognized, regional organizations, tribally controlled colleges and universities (TCCUs), eligible federal government agencies, and U.S. territories or possessions.

The opportunity is strictly domestic in scope with respect to applicants and project components. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. In practical terms, applicants must plan for the work to be led and carried out within allowable U.S.-based organizational and project structures, without foreign subcomponents that NIH would classify as foreign components.

Overall, this FOA is meant for teams that have a promising idea for improving prevention or treatment service delivery for polysubstance use, but that need a focused, time-limited pilot phase to test feasibility, refine the model, and work through implementation realities before pursuing a larger, more expensive effectiveness trial. It is geared toward producing actionable, trial-ready evidence: not only whether a personalized service approach can help, but how it can be delivered reliably, scaled responsibly, and sustained in real-world settings serving people with complex polysubstance use needs.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Pilot and Feasibility Trials to Improve Prevention and Treatment Service Delivery for Polysubstance Use (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 $225,000.00 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.

Apply for RFA DA 22 048

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: