Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

NCT07516405 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 25-2070UG3AG094957
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Frequency and severity of adverse events; Proportion of participants who complete the intervention, do not advance to the second dose, and who withdraw early from the trial

  up to 14 weeks

Secondary Outcomes (4)

• Total drug exposure (Area Under the Curve, AUC)

  Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)

• Elimination Half-life

  Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)

• Maximum concentration (Cmax)

  Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)

• Minimum concentration (Cmin)

  Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)

Other Outcomes (3)

• Psychedelic Experience (Exploratory)

  Enrollment/Baseline study visit, Week 2, and Week 6 of study participation

• Well-being & Participant Feedback (Exploratory)

  Enrollment/Baseline study visit, Week 2, Week 6, Week 10, and Week 14 of study participation

• Pain (Exploratory, optional)

  Enrollment/Baseline study visit, Week 2, and Week 6 of study participation

Study Arms (1)

Psilocybin

EXPERIMENTAL

Two escalating doses of psilocybin 30 days apart

Drug: Psilocybin (Usona Institute)

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.

Psilocybin

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65-85 years \& be male, female, or non-binary
• Generally healthy
• Have an identified support person
• Capacity to Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Emory University: collaborator
• NYU Langone Health: collaborator
• University of Colorado, Denver: lead
• University of California, San Francisco: collaborator
• Dana-Farber Cancer Institute: collaborator
• University of Nebraska: collaborator

Study Sites (6)

University of California San Francisco (UCSF) Department of Neurology

San Francisco, California, 94158, United States

RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Emory University Brain Health Center

Atlanta, Georgia, 30329, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

NOT YET RECRUITING

New York University Langone Health, Center for Psychedelic Medicine

New York, New York, 10016, United States

NOT YET RECRUITING

MeSH Terms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Central Study Contacts

Mary P Mancuso, MA (dual degrees)

CONTACT

3037245729; inspire@cuanschutz.edu

Lila Harris, BS

CONTACT

lila.m.harris@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort model: each cohort will receive 2 escalating doses of psilocybin 30 days apart. The first 20 participants will follow this schema: Cohort 1a: Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg) 30 days apart. If tolerated in the first 20 participants, the second 20 participants will follow this schema: Cohort 1b: Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-07

Locations

US (6)