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Not yet recruitingPhase 1

Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life

NCT07719088 · LONG-LIFE · Charles Raison

Closed to entry
Status
Not accepting participants
Phase 1
Phase
50
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Epigenetic/Biological Clock Profiling from Baseline to Week 4 and Week 16

    Measured over Change from Baseline to Week 4 and Week 16

  • Change in Purpose in Life (PIL) from Baseline to Week 4 and Week 16

    Measured over Change from Baseline to Week 4 and Week 16

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

60 Years to 80 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * English speaking and able to provide informed consent and complete study procedures * Medically healthy, as determined by the screening physician, with no significant medical conditions that would interfere with participation or affect the safety of the subject. Exclusion Criteria: * History or presence of any psychiatric or medical condition that, in the opinion of the investigator, could pose a safety risk, interfere with participation, or confound study results. * Abnormal ECG at screening that may increase risk during participation (e.g., prolonged QTc, arrhythmias, or other clinically significant findings as determined by the study physician). * Unwilling or unable to discontinue medications that may interfere with study participation, as determined by the investigator.

Where

1 study site

FacilityCityRegionCountry
Vail Health Behavioral HealthEdwardsColoradoUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07719088 on ClinicalTrials.gov →

Last updated in the registry 2026-08-17. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication

Recruiting in

All 2 trials from Charles Raison →