Recruiting
Phase 1

Psilocybin

Sponsor:

University of Colorado, Denver

Code:

NCT07516405

Conditions

Healthy Volunteer

Older Adults (65-85 Years)

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

Psilocybin (Usona Institute)

Study Details

Brief summary:

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

Conditions

Healthy Volunteer

Older Adults (65-85 Years)

Study ID

NCT07516405

Start date

Apr 1, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Psilocybin

Two escalating doses of psilocybin 30 days apart

Interventions

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.

Primary outcome measure

  • Adverse Events [ Time Frame: up to 14 weeks ]

Central Contacts and Locations

Central contacts

Mary P Mancuso, MA (dual degrees)

3037245729inspire@cuanschutz.edu

Lila Harris, BS

lila.m.harris@cuanschutz.edu

Locations

University of California San Francisco (UCSF) Department of Neurology

Recruiting

San Francisco, California, United States, 94158

Contacts

Jennifer Mitchell, PhD

510-985-3522psy.elder@ucsf.edu

Principal Investigator:

Jennifer Mitchell, PhD

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Mary Mancuso, MS

303-724-5729inspire@cuanschutz.edu

Principal Investigator:

Stacy Fischer, MD

Emory University Brain Health Center

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Tanja Mletzko, MA

404-778-6663study@emory.edu

Joyelle Van Eron, MPH

404-727-8966jvanero@emory.edu

Principal Investigator:

Ali John Zarrabi, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Gabriel Najarian

patresearch@dfci.harvard.edu

Principal Investigator:

Yvan Beaussant, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68105

Contacts

Jennifer Wettschreck, MS

402-559-3342jemurray@unmc.edu

Principal Investigator:

Lou Lukas, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • healthy older adults ages 65-85
  • psilocybin safety
  • psilocybin tolerability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-08-10.