Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Colorado, Denver
Study ID
NCT07516405
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Volunteer
  • Older Adults (65-85 Years)

Eligibility Criteria

Sex
ALL
Age
65 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Psilocybin (Usona Institute) — DRUG
    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.

Study Details

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

Key Dates

Start date
Apr 1, 2026
Status verified
May 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Psilocybin
    Two escalating doses of psilocybin 30 days apart

Primary Outcome Measure

Adverse Events [ Time Frame: up to 14 weeks ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California San Francisco (UCSF) Department of NeurologySan FranciscoCalifornia94158
Jennifer Mitchell, PhD
[email protected]
510-985-3522
Jennifer Mitchell, PhD (PRINCIPAL_INVESTIGATOR)
University of Colorado Anschutz Medical CampusAuroraColorado80045
Mary Mancuso, MS
[email protected]
3037245729
Lila Harris, BA
Stacy Fischer, MD (PRINCIPAL_INVESTIGATOR)
Emory University Brain Health CenterAtlantaGeorgia30329
Tanja Mletzko, MA
[email protected]
404-778-6663
Joyelle Van Eron, MPH
[email protected]
404-727-8966
Ali John Zarrabi, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Gabriel Najarian
[email protected]
Yvan Beaussant, MD (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68105
Jennifer Wettschreck, MS
[email protected]
402.559.3342
Lou Lukas, MD (PRINCIPAL_INVESTIGATOR)
New York University Langone Health, Center for Psychedelic MedicineNew YorkNew York10016
Denise Balili, MS
[email protected]
646-501-2623
Stephen Ross, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
University of California San Francisco (UCSF) Department of Neurology· San Francisco, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COEmory University Brain Health Center· Atlanta, GADana-Farber Cancer Institute· Boston, MAUniversity of Nebraska Medical Center· Omaha, NENew York University Langone Health, Center for Psychedelic Medicine· New York, NY

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