Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07719088

Psilocybin Effects on Healthy Aging Biomarkers 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Aging Biomarkers of Aging Longevity

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vail Health Behavioral Health

Edwards, Colorado, 81632, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psilocybin (Usona Institute)

Drug

25mg capsule of psilocybin

Primary outcomes

  1. 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

  2. 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).

Secondary outcomes

  1. 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

  2. Change in Telomere Length from Baseline to Week 52

    Time frame: Change from Baseline to Week 52

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

BHIC Study Team

CONTACT

[email protected]

970-855-7374

Sponsors and collaborators

Lead sponsor

Charles Raison

Other

Collaborators

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

Registry information

Official study title

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

Acronym: LONG-LIFE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.