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RECRUITING
NCT07516405
PHASE1

Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.

Official title: A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

Key Details

Gender

All

Age Range

65 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-04-01

Completion Date

2028-03

Last Updated

2026-04-08

Healthy Volunteers

Yes

Interventions

DRUG

Psilocybin (Usona Institute)

Evaluate the safety and tolerability of psychedelic administration in two cohorts of healthy older adults. * Cohort 1a Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg) 30 days apart. * Cohort 1b Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart.

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