Safety and Tolerability Trial of Psilocybin in Healthy Older Adults (NCT07516405) | Clinical Trial Compass
RecruitingPhase 1
Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
United States40 participantsStarted 2026-04-01
Plain-language summary
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
Who can participate
Age range
65 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.