Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults (UG3/UH3 Clinical Trial Required) | RFA AG 25 004

Opportunity Information: Apply for RFA AG 25 004

This NIH funding opportunity (RFA-AG-25-004) supports the creation of a multi-center consortium that operates as a clinical trials network focused on psychedelic-assisted therapy for chronic pain in older adults. The central goal is to generate rigorous safety data and early signs of efficacy in well-defined groups of older people who have specific chronic pain conditions. Rather than funding a single-site pilot, the announcement is geared toward building coordinated, multi-site capacity to run harmonized studies, gather comparable data across locations, and move the field toward evidence that is actually applicable to older adults as they are seen in real clinical settings.

The award uses the UG3/UH3 phased innovation structure under a Cooperative Agreement, meaning NIH will be substantially involved in oversight and collaboration rather than acting as a purely hands-off funder. Applicants have to submit one integrated application that clearly lays out both phases. The UG3 phase is the front-end planning and preliminary data period (up to 2 years). During UG3, the expectation is to run early studies in healthy older adults spanning a broad age range to characterize safety and tolerability and to collect pharmacokinetic and pharmacodynamic information for the selected psychedelic agent(s). This phase is also meant to de-risk the later trials by testing and refining key elements such as recruitment and retention approaches for older participants, dosing and monitoring procedures, therapist training and fidelity methods for the psychotherapy component, outcome measures, and overall site workflows that will later be used in the patient trials.

If UG3 milestones are met, the project transitions to the UH3 phase (up to 3 years), which is designed to expand safety evaluation and begin assessing preliminary efficacy in older adults who actually have chronic pain conditions. A notable feature of the UH3 expectations is the emphasis on real-world relevance: participants may include older adults with co-occurring conditions as long as those conditions are not contraindications to study participation. This is intended to avoid overly idealized samples and instead reflect the medical complexity commonly seen in geriatric pain populations, improving the practical value of the findings.

Across both phases, the age distribution requirement is explicit. Studies should include participants across a broad range of older ages, with special attention to the upper end of the age spectrum, including strata around 75-80 years and those age 80 and older. In other words, this is not just an "older adult" study in name only; the design is expected to intentionally include the oldest participants who are often missing from earlier psychedelic research, and to examine safety and response patterns in those age bands.

The announcement defines "psychedelic" broadly but also draws clear boundaries. Eligible agents include classic psychedelics that are typically understood as 5-HT2 receptor agonists, specifically naming psilocybin, N,N-Dimethyltryptamine (DMT), lysergic acid diethylamide (LSD), and mescaline, along with entactogens/empathogens such as MDMA. Synthetic analogs of these substances are also included. At the same time, the RFA states that cannabis and ketamine (and related products) are not considered psychedelic agents for the purposes of this competition, so projects centered on those compounds would be non-responsive.

Eligibility is broad and includes many common NIH applicant types: state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; tribal governments (federally recognized) and tribal organizations (including other than federally recognized); public housing/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The RFA also explicitly calls out additional eligible applicant categories such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian serving institutions, tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. On the international side, non-U.S. (foreign) organizations are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, foreign components are allowed as defined by NIH policy, meaning a U.S. applicant could include certain approved foreign elements within the project if justified and permitted under NIH rules.

Administratively, the opportunity is run by the National Institutes of Health, falls under a health-related activity category, and uses CFDA numbers 93.213 and 93.866. The original closing date listed is October 10, 2024, and the posting date is April 24, 2024. The award ceiling and expected number of awards are not specified in the provided listing, which often means applicants need to look to the full NIH announcement or budget guidance to understand typical funding levels and consortium expectations.

Taken together, the opportunity is essentially asking teams to build a coordinated, multi-site clinical trials network that can responsibly test psychedelic-assisted therapy in older adults with chronic pain, starting with careful safety and dose/response characterization in healthy older participants (UG3) and then moving into larger, more clinically representative patient studies that examine both safety and early efficacy signals (UH3), with deliberate inclusion of the oldest age groups who are most likely to have different risk profiles and treatment responses.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults (UG3/UH3 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.866.
• This funding opportunity was created on 2024-04-24.
• Applicants must submit their applications by 2024-10-10. (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.

Apply for RFA AG 25 004

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