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

August 13, 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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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). Scores range from 5 to 35, where higher scores indicate greater satisfaction with life.
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). Scores range from 14 to 70, with higher scores indicating higher mental wellbeing.
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). Scores range from 0 to 24, with higher scores indicating higher dispositional optimism.
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). Scores range from 7 to 28; higher totals indicate greater self-mastery.
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). Scores range from 3 to 9. Higher scores indicate a greater degree of loneliness.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charles Raison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20262840

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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