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Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
RecruitingPhase 1Healthy volunteers welcome
A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
Who can join
Ages 65 to 85 · All sexes · Healthy volunteers welcome
Full eligibility 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
About the study
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
What is being tested
- Psilocybin (Usona Institute) (drug)
Sponsor: University of Colorado, Denver · Participants: 40 · Started: Apr 1, 2026
Contact the study team
- Mary P Mancuso, MA (dual degrees) · Phone: 3037245729
Official record on ClinicalTrials.gov — NCT07516405
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.