Psychedelics Treatment Research in Substance Use Disorder (UG3/UH3 Clinical Trials Optional) | RFA DA 25 058

Opportunity Information: Apply for RFA DA 25 058

The Psychedelics Treatment Research in Substance Use Disorder (UG3/UH3 Clinical Trials Optional) opportunity (Funding Opportunity Number RFA-DA-25-058) is a National Institutes of Health (NIH) cooperative agreement aimed at advancing clinical research on psychedelic-assisted treatments for alcohol and substance use disorders (ASUD). The core purpose is to strengthen the evidence base for how these treatments should be delivered in real-world clinical contexts by improving and optimizing administration paradigms, clarifying the contribution of psychotherapy within psychedelic treatment models, and capturing a fuller picture of patient outcomes beyond symptom change alone. In practical terms, the program is looking for well-designed clinical studies that do more than test whether a psychedelic intervention works; it prioritizes understanding how to administer these interventions effectively, safely, and consistently, and how to measure both clinical benefits and downstream functional effects that matter in recovery (for example, functioning in work, relationships, daily living, and other longer-term indicators of stability and quality of life).

A key emphasis of this opportunity is the refinement of psychedelic treatment administration paradigms, which includes the full treatment package surrounding psychedelic delivery. That can involve questions about preparation procedures, dosing or session structure, therapeutic setting and support, follow-up integration, and the operational details needed to run these interventions under clinical research conditions. Because psychedelic-assisted approaches are often paired with psychotherapy, the opportunity explicitly encourages research that examines the role psychotherapy plays in outcomes, such as whether certain therapy components are essential, which elements are most influential, and how psychotherapy should be structured around the medication session(s). The announcement also signals interest in novel clinical trial designs, reflecting that the ASUD research field is actively exploring methods that can better capture the complexity of these interventions, their mechanisms, and the range of outcomes they may influence.

The UG3/UH3 structure generally supports a phased approach to clinical research, with an initial planning and milestone-driven phase (UG3) that can transition into an implementation phase (UH3) once predefined readiness criteria are met. This format is often used when studies require substantial upfront development, coordination, or feasibility work before launching full execution. The notice indicates that clinical trials are optional, meaning applicants may propose clinical studies that do not necessarily meet NIHs definition of a clinical trial, or they may propose clinical trials depending on the research question and design. Because this is a cooperative agreement, recipients should expect substantial scientific and programmatic involvement from NIH staff compared to a standard grant, typically through collaborative oversight, milestones, and coordination expectations.

Eligibility is broad and includes many types of domestic entities, such as state, county, city, township, and 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; Native American tribal organizations that are not federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The opportunity also highlights additional eligible applicants and organizational types of particular interest, including 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, regional organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This breadth suggests NIH is open to a wide range of research settings and partnerships, including those that can reach diverse populations or bring specialized clinical and community infrastructure to psychedelic-ASUD research.

From a funding and administrative standpoint, the program is listed as discretionary and uses the cooperative agreement funding instrument. The associated CFDA number is 93.279. The award ceiling is $2,000,000, signaling support for sizable projects that may involve multi-site coordination, complex clinical operations, specialized staff training, or intensive participant follow-up. The original closing date is listed as 2024-02-28, and the opportunity was created on 2023-11-01. While the expected number of awards is not specified in the provided data, the scale and structure indicate NIH is targeting projects with clear milestones, strong operational plans, and meaningful contributions to optimizing psychedelic treatment approaches for substance use disorders.

Overall, this opportunity is focused on moving psychedelic-assisted interventions for ASUD toward more rigorous, implementable, and clinically informative evidence. It encourages applicants to think carefully about how the treatment is delivered (not just what is delivered), how psychotherapy and non-pharmacologic supports shape outcomes, and how to measure both clinical endpoints and longer-term functional changes that reflect real recovery trajectories.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Psychedelics Treatment Research in Substance Use Disorder (UG3/UH3 Clinical Trials Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2023-11-01.
• Applicants must submit their applications by 2024-02-28. (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 $2,000,000.00 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 25 058

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