Clinical TrialOlder AdultsPsilocybinRecruiting

Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

This Phase I, single-group trial (n=40) will assess the safety and tolerability of oral psilocybin in healthy older adults aged 65 to 85 years. It will evaluate two dose cohorts, with the main aim of determining whether psilocybin can be administered safely in this population and how it is tolerated over time. Participants will receive two escalating oral doses of psilocybin 30 days apart: Cohort 1a will receive 10 mg followed by 25 mg, and Cohort 1b will receive 15 mg followed by 30 mg. The study will also examine pharmacokinetics, patient-reported outcomes such as psychedelic experience and wellbeing, and relationships between drug exposure, safety findings, and reported effects. Safety outcomes include adverse events assessed for up to 14 weeks.

Target Enrollment
40 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

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

Study Arms & Interventions

Psilocybin

experimental

Two escalating doses of psilocybin 30 days apart

Interventions

  • Psilocybin10 - 25 mg
    via Oral• 2 doses 30 days apart• 2 doses total

Participants

Ages
65 – 85
Sexes
Male & Female

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 Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment40 participants
  • Timeline
    Start: 2026-04-01
    End: 2028-03-01
  • Compound
    Psilocybin
  • Topic
    Older Adults

Locations

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

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