AgingPhase 1LONG-LIFENCT07719088
Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life
A Phase 1 study testing Psilocybin (Usona Institute) in people with Aging and Longevity, run by Charles Raison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Longevity, Biomarkers of Aging
- What is being tested?
- Psilocybin (Usona Institute)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vail Health Behavioral Health
Edwards, Colorado, 81632
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging, Longevity, Biomarkers of Aging
- Being tested
- Psilocybin (Usona Institute)
- Keywords
- Aging, Longevity, Cognitive Function, Purpose, Meaning, Well-Being, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (Usona Institute)Drug
25mg capsule of psilocybin
| Study group | Role | What they receive |
|---|---|---|
| One 25mg Dose of Psilocybin | Experimental | Participants in this arm will receive one 25mg dose of psilocybin paired with therapeutic support. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: Change from Baseline to Week 4 and Week 16
Secondary outcomes (8)
Change in Epigenetic/Biological Clock Profiling from Baseline to Week 52
Change in Epigenetic/biological clock profile from Baseline to Week 52
Measured: Change from Baseline to Week 52
Change in Telomere Length from Baseline to Week 52
Measured: Change from Baseline to Week 52
Change in Purpose in Life (PIL) 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).
Measured: Change from Baseline to Week 52
Change in Satisfaction with Life 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.
Measured: Change from Baseline to Week 4 and Week 16
Change in Wellbeing 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.
Measured: Change from Baseline to Week 4 and Week 16
Change in Optimism 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.
Measured: Change from Baseline to Week 4 and Week 16
Change in Perceived Control/Mastery 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.
Measured: Change from Baseline to Week 4 and Week 16
Change in Loneliness 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.
Measured: Change from Baseline to Week 4 and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles Raison
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, Steadman Philippon Research Institute, Emory University, University of Wisconsin, Madison, Usona Institute
- Responsible party
- Sponsor-investigator, Charles Raison, Vail Health Behavioral Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719088
- Sponsor's protocol ID
- 20262840
- Acronym
- LONG-LIFE
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of Psilocybin Effects on Biomarkers of Longevity, Healthy Aging, and Purpose in Life
- ClinicalTrials.gov ID
- NCT07719088
- Acronym / sponsor ID
- LONG-LIFE / 20262840
- Conditions
- Aging, Longevity, Biomarkers of Aging
- Keywords
- Aging, Longevity, Cognitive Function, Purpose, Meaning, Well-Being, Biomarkers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charles RaisonUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, Steadman Philippon Research Institute, Emory University, University of Wisconsin, Madison, Usona Institute
- Study start
- Dec 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| One 25mg Dose of Psilocybin | Experimental | Drug: Psilocybin (Usona Institute)Participants in this arm will receive one 25mg dose of psilocybin paired with therapeutic support. |
| Two 25mg Doses of Psilocybin | Experimental | Drug: Psilocybin (Usona Institute)Participants in this arm will receive two 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support. |
| Three 25mg Doses of Psilocybin | Experimental | Drug: Psilocybin (Usona Institute)Participants in this arm will receive three 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support. |
| 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin (Usona Institute)25mg capsule of psilocybin | Drug | One 25mg Dose of Psilocybin, Three 25mg Doses of Psilocybin, Two 25mg Doses of Psilocybin |
Primary outcome
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 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).
8 secondary outcomes
Change in Epigenetic/Biological Clock Profiling from Baseline to Week 52
Time frame: Change from Baseline to Week 52
Change in Telomere Length from Baseline to Week 52
Time frame: 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 in Satisfaction with Life from Baseline to Week 4 and Week 16
Time frame: 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
Change in Optimism from Baseline to Week 4 and Week 16
Time frame: 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
Change in Loneliness from Baseline to Week 4 and Week 16
Time frame: Change from Baseline to Week 4 and Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Vail Health Behavioral Health Innovation Center WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin (Usona Institute) in people with Aging and Longevity, run by Charles Raison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BHIC Study Team (970-855-7374, bhic@vailhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.