Actively Recruiting
Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
Led by University of Colorado, Denver · Updated on 2026-05-11
40
Participants Needed
6
Research Sites
100 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
CONDITIONS
Official Title
Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 65-85 years and be male, female, or non-binary
- Generally healthy
- Have an identified support person
- Capacity to Consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University of California San Francisco (UCSF) Department of Neurology
San Francisco, California, United States, 94158
Actively Recruiting
2
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Emory University Brain Health Center
Atlanta, Georgia, United States, 30329
Not Yet Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
5
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68105
Not Yet Recruiting
6
New York University Langone Health, Center for Psychedelic Medicine
New York, New York, United States, 10016
Not Yet Recruiting
Research Team
M
Mary P Mancuso, MA (dual degrees)
CONTACT
L
Lila Harris, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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