Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life (LONG-LIFE)

July 16, 2026 updated by: Charles Raison

An Examination of Psilocybin Effects on Biomarkers of Longevity, Healthy Aging, and Purpose in Life

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Aging is accompanied by progressive changes across multiple physiological systems that contribute to functional decline and increased risk for age-related disease. Biomarkers of biological aging, including DNA methylation-based epigenetic clocks, have emerged as tools for assessing age-related biological processes and predicting future health outcomes.

Recent preclinical studies have suggested that psilocybin and its active metabolite, psilocin, may influence several pathways implicated in aging, including cellular senescence, oxidative stress, neuroplasticity, and epigenetic regulation. In addition to biological effects, observational studies have demonstrated associations between psychosocial factors, including purpose in life and social connectedness, and reduced morbidity and mortality in older adults. Previous clinical studies have shown that psilocybin may produce changes in psychological well-being, meaning, and related constructs.

The LONG-LIFE Study is designed to evaluate multiple domains relevant to healthy aging, including, but not limited to, epigenetic and biological clock measures, cognitive performance, psychosocial well-being, and ecological momentary assessments of daily experience.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Edwards, Colorado, United States, 81632
        • Vail Health Behavioral Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One 25mg Dose of Psilocybin
Participants in this arm will receive one 25mg dose of psilocybin paired with therapeutic support.
Drug: Psilocybin (Usona Institute)
25mg capsule of psilocybin
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.
Drug: Psilocybin (Usona Institute)
25mg capsule of psilocybin
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.
Drug: Psilocybin (Usona Institute)
25mg capsule of psilocybin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Change 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Epigenetic/Biological Clock Profiling from Baseline to Week 52
Time Frame: Change from Baseline to Week 52
Change in Epigenetic/biological clock profile from Baseline to Week 52
Change from Baseline to Week 52
Change in Telomere Length from Baseline to Week 52
Time Frame: Change from Baseline to Week 52
Change from Baseline to Week 52
Change in Purpose in Life (PIL) from Baseline to Week 52
Time Frame: Change from Baseline to Week 52
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 52
Change in Satisfaction with Life from Baseline to Week 4 and Week 16
Time Frame: Change from Baseline to Week 4 and Week 16
Measured using the Satisfaction With Life Scale (SWLS)
Change from Baseline to Week 4 and Week 16
Change in Wellbeing from Baseline to Week 4 and Week 16
Time Frame: Change from Baseline to Week 4 and Week 16
Measured using the Warwick Edinburgh Mental Well-Being Scale (WEMWBS)
Change from Baseline to Week 4 and Week 16
Change in Optimism from Baseline to Week 4 and Week 16
Time Frame: Change from Baseline to Week 4 and Week 16
Measured using the Life Orientation Test - Revised (LOT-R)
Change from Baseline to Week 4 and Week 16
Change in Perceived Control/Mastery from Baseline to Week 4 and Week 16
Time Frame: Change from Baseline to Week 4 and Week 16
Measured using the Pearlin Mastery Scale (PM)
Change from Baseline to Week 4 and Week 16
Change in Loneliness from Baseline to Week 4 and Week 16
Time Frame: Change from Baseline to Week 4 and Week 16
Measured using the 3-Item UCLA Loneliness Scale (UCLA-3)
Change from Baseline to Week 4 and Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles Raison

Collaborators

Baylor College of Medicine
University of Wisconsin, Madison
Emory University
Usona Institute
Steadman Philippon Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND182485

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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