Phase 1Not yet recruitingHealthspan endpoint
Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life (LONG-LIFE)
An Examination of Psilocybin Effects on Biomarkers of Longevity, Healthy Aging, and Purpose in Life
- Sponsor
- Charles Raison (Academic or other)
- Enrolment
- 50 planned
- Conditions
- Aging; Longevity; Biomarkers of Aging
- Interventions
- Psilocybin (Usona Institute)
- Ages
- adults, older adults
- Registry
- NCT07719088
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Change in Epigenetic/Biological Clock Profiling from Baseline to Week 4 and Week 16
- Change in Purpose in Life (PIL) from Baseline to Week 4 and Week 16
History
Study completion expected
Primary completion expected
Expected to start
Last registry update
Registered