Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life

NCT07719088 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IND182485
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Longevity; Biomarkers of Aging

Keywords

Aging; Longevity; Cognitive Function; Purpose; Meaning; Well-Being; Biomarkers

Outcome Measures

Primary Outcomes (2)

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

  Epigenetic/biological clock profiles; change from Baseline to Week 4 and 16

  Change from Baseline to Week 4 and Week 16

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

  Change from baseline in Purpose in Life score measured using the 7-item Purpose in Life Scale (PIL) from the Health and Retirement Study (score range 1-6; higher scores indicate greater purpose in life).

  Change from Baseline to Week 4 and Week 16

Secondary Outcomes (8)

• Change in Epigenetic/Biological Clock Profiling from Baseline to Week 52

  Change from Baseline to Week 52

• Change in Telomere Length from Baseline to Week 52

  Change from Baseline to Week 52

• Change in Purpose in Life (PIL) from Baseline to Week 52

  Change from Baseline to Week 52

• Change in Satisfaction with Life from Baseline to Week 4 and Week 16

  Change from Baseline to Week 4 and Week 16

• Change in Wellbeing from Baseline to Week 4 and Week 16

  Change from Baseline to Week 4 and Week 16

Study Arms (4)

One 25mg Dose of Psilocybin

EXPERIMENTAL

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

Drug: Psilocybin (Usona Institute)

Two 25mg Doses of Psilocybin

EXPERIMENTAL

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 Psilocybin

EXPERIMENTAL

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 Comparator

NO 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.

Interventions

Psilocybin (Usona Institute) DRUG

25mg capsule of psilocybin

One 25mg Dose of Psilocybin; Three 25mg Doses of Psilocybin; Two 25mg Doses of Psilocybin

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charles Raison: lead
• Baylor College of Medicine: collaborator
• Steadman Philippon Research Institute: collaborator
• Emory University: collaborator
• University of Wisconsin, Madison: collaborator
• Usona Institute: collaborator

Study Sites (1)

Vail Health Behavioral Health

Edwards, Colorado, 81632, United States

Location

Related Links

• Vail Health Behavioral Health Innovation Center Website

MeSH Terms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Central Study Contacts

BHIC Study Team

CONTACT

970-855-7374; bhic@vailhealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Vail Health Behavioral Health Innovation Center

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)