Advancing Psychedelics Research for Treating Addiction (R61/R33 Clinical Trial Required) | RFA DA 24 024

Opportunity Information: Apply for RFA DA 24 024

The grant opportunity titled "Advancing Psychedelics Research for Treating Addiction (R61/R33 Clinical Trial Required)" (Funding Opportunity Number RFA-DA-24-024) is a National Institutes of Health (NIH) discretionary grant aimed at accelerating both basic and clinical research on psychedelic compounds as potential treatments for substance use disorders (SUD). The central focus is to push the field beyond broad therapeutic promise and toward clear, evidence-based understanding of how psychedelics work in addiction-related contexts, including what biological targets they engage, what mechanisms drive any therapeutic effects, and what practical translational factors (like dosing, safety, and real-world feasibility) need to be resolved to responsibly move these interventions forward.

A major theme of this funding announcement is the expectation of multidisciplinary projects that connect mechanistic science with clinical testing. The FOA emphasizes systematically evaluating psychedelics as neurotherapeutics, meaning applicants are expected to go beyond general clinical outcomes and help clarify drug-target engagement and mechanisms of action. In practical terms, that can include research that links observed clinical changes to measurable biological or neurological markers, and studies that connect pharmacology with behavioral outcomes relevant to addiction. Alongside mechanism work, the FOA explicitly highlights other translational priorities such as safety and tolerability, pharmacokinetics and pharmacodynamics (PK/PD), and efficacy within SUD populations. Taken together, the opportunity is structured to address key knowledge gaps that often block psychedelics research from progressing into rigorous, reproducible, clinically actionable treatment strategies for addiction.

The award mechanism is an R61/R33, which generally reflects a phased approach to research and development. While the FOA text provided does not spell out the phase details, R61/R33 funding opportunities typically support an initial milestone-driven development phase (R61) followed by a second phase (R33) that expands or confirms findings once predefined milestones are met. The title also makes clear that a clinical trial is required, so proposals should be designed with clinical testing as a core component rather than an optional add-on. This requirement signals that the sponsor is looking for projects capable of generating human-subject evidence and not solely preclinical or theoretical work, even though the FOA also values basic and translational science that helps interpret and de-risk the clinical results.

In terms of the specific scientific scope, the FOA is oriented toward building a more complete translational package around psychedelics in addiction treatment. That includes understanding how the drug interacts with targets in the brain or body, how those interactions relate to changes in craving, withdrawal, relapse risk, or other addiction-relevant endpoints, and how PK/PD properties may vary across individuals or substances of abuse. The emphasis on safety is also important in this area, since psychedelic-assisted approaches may involve distinctive acute effects and contextual considerations that require careful monitoring and well-justified clinical protocols. The overall intent is not just to show that a psychedelic intervention might help, but to explain why it helps, for whom, under what conditions, and with what risk profile.

Eligibility for this opportunity is broad and includes many organization types across government, academia, nonprofit, and industry. Eligible applicants listed 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 and Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly calls out additional eligible applicant categories, 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 even non-U.S. entities (foreign organizations). This wide eligibility suggests the NIH is encouraging participation from diverse institutional settings, including community-based and international partners, as long as the proposed research meets the scientific and regulatory expectations for a clinical trial.

From the funding snapshot provided, the opportunity is associated with CFDA number 93.279 and is categorized under education and health. The original closing date listed is 2023-11-02, and the FOA creation date is 2023-05-16. An award ceiling of $700,000 is specified, indicating a cap on the maximum award amount (though the number of expected awards is not provided in the text you shared). Applicants would need to design a project that fits within the budget structure while still supporting the required clinical trial and the supporting mechanistic and translational measurements emphasized in the announcement.

Overall, this FOA is positioned for teams that can combine strong clinical trial execution with rigorous translational science to answer not only whether psychedelic-based approaches can improve SUD outcomes, but also how they work at a biological and pharmacological level, how to measure meaningful target engagement, and how to characterize safety and PK/PD in relevant populations. It is essentially an invitation to move psychedelics research for addiction into a more mature, evidence-driven phase where mechanisms, dosing logic, safety parameters, and efficacy data are developed together in a way that can support future clinical practice and later-stage research.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Advancing Psychedelics Research for Treating Addiction (R61/R33 Clinical Trial Required)" 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 2023-05-16.
• Applicants must submit their applications by 2023-11-02. (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 $700,000.00 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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