RecruitingPhase 1psilocybin
Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
Sponsored by University of Colorado, Denver
NCT ID
NCT07516405
Target Enrollment
40 participants
Start Date
2026-04-01
Est. Completion
2028-03
About This Study
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
Conditions Studied
Interventions
- •Psilocybin (Usona Institute)
Eligibility
Age:65 Years - 85 Years
Healthy Volunteers:Yes
View 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
Study Locations (6)
University of California San Francisco (UCSF) Department of Neurology
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Emory University Brain Health Center
Atlanta, Georgia, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
New York University Langone Health, Center for Psychedelic Medicine
New York, New York, United States