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NCT07719088

Overview

NCT ID: NCT07719088
Lead Sponsor: Charles RaisonOTHER
Official Title: An Examination of Psilocybin Effects on Biomarkers of Longevity, Healthy Aging, and Purpose in Life
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Dec 2026Estimated
Primary Completion Date: Apr 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Phase 1
Enrollment: 50Estimated
Primary Purpose: Other
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: BHIC Study TeamContact
bhic@vailhealth.org970-855-7374

Similar Studies

Participant Group/Arms

One 25mg Dose of PsilocybinExperimental

Participants in this arm will receive one 25mg dose of psilocybin paired with therapeutic support.

Drug: Psilocybin (Usona Institute)

Two 25mg Doses of PsilocybinExperimental

Participants in this arm will receive two 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support.

Drug: Psilocybin (Usona Institute)

Three 25mg Doses of PsilocybinExperimental

Participants in this arm will receive three 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support.

Drug: Psilocybin (Usona Institute)

Wait-list ComparatorNo Intervention

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.