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

National Institutes of Health

This NOFO invites applications to support a clinical trials network involving multiple institutions to collect safety and early efficacy data of psychedelic-assisted therapy (PAT) in defined groups of older adults living with specific chronic pain conditions.

This NOFO uses the UG3 / UH3 Exploratory/Developmental Phased Award Cooperative Agreement activity code . Applications must include a research plan describing both UG3 and UH3 phases. The first phase, the UG3 phase, may last up to two years, and should involve preliminary studies in healthy older adults across a broad age range to evaluate safety, pharmacokinetic, and pharmacodynamic properties of psychedelic agents and preliminary testing of PAT elements.

Activities in the UG3 phase will inform further development and testing in the second phase, the UH3 phase.

The UH3 phase may last up to 3 years and should include expanded safety and preliminary efficacy studies in older adults with chronic pain conditions and must include participants living with non-contraindicated co-occurring conditions representative of real-world older adults.

In both phases, participants across a broad range of ages must be included, with particular attention to strata at the upper age range (i.e., 75-80 years, and 80+ years old).

For the purposes of this NOFO, the term psychedelic includes “classic” psychedelics, typically understood to be 5-HT2 agonists such as psilocybin, N,N-Dimethyltryptamine (DMT), lysergic acid diethylamide (LSD), and mescaline, as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA). Synthetic analogs of these agents are also included. Cannabis, ketamine, and their related products are not considered psychedelic agents in this NOFO.

Deadlines:

Letter of Intent Due Date(s): September 10, 2024
Application Due Date: October 10, 2024

RFA-AG-25-004 Expiration Date October 11, 2024

Specialties

Medical

Medical - Translational

Medical - Clinical Science

Eligibility Requirements

Study teams must have demonstrated experience to successfully achieve the goals of this NOFO, including expertise in psychedelic-assisted therapy, management of chronic pain, geriatrics/aging and multimorbidity, and management of multi-site clinical trials.