Psilocybin safety and tolerability in healthy adults ages 65–85
Official title: A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
Run by University of Colorado, Denver · NCT07516405 · Data updated 2026-11-12
This project will test whether two oral doses of psilocybin given one month apart are safe and tolerable for generally healthy adults aged 65 to 85.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 6 sites (San Francisco, California and 5 other locations) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | March 2028 |
| Study ends | March 2028 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT07516405 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Generally healthy adults aged 65–85 who can give informed consent, have an identified support person, and do not have unstable medical or excluded psychiatric conditions are ideal candidates.
✕Probably not a fit
People with uncontrolled hypertension, significant CNS disease, primary psychotic or serious bipolar disorders, active substance use disorders, extensive prior serotonergic hallucinogen use, or who take contraindicated serotonergic or interacting medications are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 study enrolls healthy volunteers aged 65–85 and gives two oral doses of psilocybin in one of two dose schedules (moderate: 10 mg then 25 mg; high: 15 mg then 30 mg) spaced 30 days apart. Participants are closely monitored for vital signs, heart rhythm, mental status, and adverse events during and after dosing, with blood sampling to measure how the body absorbs and clears psilocybin. The study also collects patient-reported measures of mood, cognition, and the psychedelic experience to explore relationships between drug levels, safety signals, and subjective effects. Safety and tolerability in these older adults will determine whether future clinical research in this age group is appropriate.
Why it matters
Potential benefit: If shown to be safe and tolerable, this work could open the door to future research of psilocybin-based therapies for older adults and improve understanding of dosing and monitoring needs in this age group.
How similar studies have gone: Previous psilocybin studies in younger or clinical populations have generally shown tolerability and informative pharmacokinetics, but dedicated safety data specifically in healthy older adults are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 65-85 years \& be male, female, or non-binary * Generally healthy * Have an identified support person * Capacity to Consent Exclusion Criteria: * Unstable medical condition * Risk for hypertensive crisis (screening blood pressure \>140/90 mmHg) * Significant central nervous system (CNS) pathology * Primary psychotic or affective psychotic disorders * Family history of psychotic or serious bipolar spectrum illnesses * High risk of adverse emotional or behavioral reaction * Active substance use disorders (SUDs) * Extensive use of serotonergic hallucinogens * High risk of completed suicide * History of hallucinogen persisting perception disorder (HPPD) * Concurrent Medications: centrally-acting serotonergic agents; antipsychotics; certain mood stabilizers, aldehyde dehydrogenase inhibitors; significant inhibitors of UGT 1A9 or UGT 1A10 * Certain psychiatric conditions * Presence of relevant finding (psychological, physical symptom, medication) prior to dosing that would make a participant unsuitable for the study
Where it's running
-
University of California San Francisco (UCSF) Department of Neurology
San Francisco, California, United States Recruiting -
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States Recruiting -
Emory University Brain Health Center
Atlanta, Georgia, United States Recruiting -
Dana-Farber Cancer Institute
Boston, Massachusetts, United States Recruiting -
University of Nebraska Medical Center
Omaha, Nebraska, United States Recruiting -
New York University Langone Health, Center for Psychedelic Medicine
New York, New York, United States Recruiting
Study contacts
- Study coordinator: Mary P Mancuso, MA (dual degrees)
- Email: inspire@cuanschutz.edu
- Phone: 3037245729
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.