Clinical Trial

Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life

Study acronym: LONG-LIFE
Not Yet Recruiting Phase 1
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Summary
The LONG-LIFE study is a randomized Phase I, dose-ranging trial designed to evaluate whether psilocybin impacts aging-related biomarkers, cognitive function, and purpose/meaning in life in medically stable older adults. Up to 50 participants will be enrolled aged 60-80 who will be randomized with equal allocation to one of four intervention groups: (1) receipt of one 25 mg dose of psilocybin; (2) receipt of two 25 mg doses of psilocybin separated by four weeks; (3) receipt of three 25 mg doses, with each dose separated by four weeks; or (4) wait-list comparator condition that does not receive psilocybin. Biomarkers of aging, cognitive performance, and behavioral measures will be assessed at baseline and longitudinally over a 12-month follow-up period. The primary endpoint occurs at the Week 16 visit. Participants randomized to the wait-list condition will be offered a single 25 mg dose of psilocybin following conclusion of the 12-month follow-up period. Findings from this Phase I study will inform dose selection for a Phase II study should results indicate a potential impact of psilocybin on relevant study endpoints.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-07-16.
Trial Details
NCT Number NCT07719088
Lead Sponsor Charles Raison
Collaborators: Baylor College of Medicine, Steadman Philippon Research Institute, Emory University, University of Wisconsin, Madison, Usona Institute
Conditions Aging, Longevity, Biomarkers of Aging
Enrollment 50 participants
Start Date 2026-12
Primary Completion 2028-04 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-24