Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life

Part of paid clinical trials in Edwards, Colorado.

Sponsor
Charles Raison
Study ID
NCT07719088
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Aging
  • Biomarkers of Aging
  • Longevity

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Psilocybin (Usona Institute) — DRUG
    25mg capsule of psilocybin

Study Details

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.

Key Dates

First listed
Jul 22, 2026
Start date
Dec 31, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: One 25mg Dose of Psilocybin
    Participants in this arm will receive one 25mg dose of psilocybin paired with therapeutic support.
  • Experimental: Two 25mg Doses of Psilocybin
    Participants in this arm will receive two 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support.
  • Experimental: Three 25mg Doses of Psilocybin
    Participants in this arm will receive three 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support.
  • No Intervention: Wait-list Comparator
    Participants in this arm will not receive psilocybin as part of the main study but will be given the opportunity to receive a single 25mg dose of psilocybin with therapeutic support after their study participation is complete.

Primary Outcome Measure

Change in Epigenetic/Biological Clock Profiling from Baseline to Week 4 and Week 16 [ Time Frame: Change from Baseline to Week 4 and Week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vail Health Behavioral HealthEdwardsColorado81632-

Find similar trials in Edwards, CO

By research site
Vail Health Behavioral Health· Edwards, CO

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