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 range65 Years – 85 Years
SexALL
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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