Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

a study on Older Adults (65-85 Years) Psilocybin

Summary

Eligibility
for people ages 65-85 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Jennifer Mitchell, PhD (ucsf)
Headshot of Jennifer Mitchell
Jennifer Mitchell

Description

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

Details

The purpose of this study is to learn whether psilocybin, a psychedelic compound, can be given safely to older adults. We want to understand how psilocybin affects the body and mind, including blood pressure, heart rhythm, and mood. We also want to see how the body processes psilocybin (how quickly it is absorbed and cleared) and whether it affects thinking, memory, or wellbeing.

  • Primary Objective: 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.
  • Secondary Objectives: Evaluate the pharmacokinetics of Psilocybin for each Cohort of healthy older adults.
  • Exploratory Objectives: Evaluate patient-reported outcomes related to Psilocybin administration (e.g., psychedelic experience and well-being) in each Cohort.

Assess the relationships between the pharmacokinetic profile, safety endpoints, and patient-reported outcomes in each Cohort.

Keywords

Healthy Volunteer, Older Adults (65-85 Years), healthy older adults ages 65-85, psilocybin safety, psilocybin tolerability, Psilocybin, Psilocybin (Usona Institute)

Eligibility

You can join if…

Open to people ages 65-85

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

You CAN'T join 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

Locations

  • University of California San Francisco (UCSF) Department of Neurology accepting new patients
    San Francisco California 94158 United States
  • University of Colorado Anschutz Medical Campus accepting new patients
    Aurora Colorado 80045 United States

Lead Scientist at University of California Health

  • Jennifer Mitchell, PhD (ucsf)
    Jennifer Mitchell is a Professor in the Departments of Neurology and Psychiatry & Behavioral Sciences and the Associate Chief of Staff for Research and Development at the San Francisco VA Medical Center.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Colorado, Denver
ID
NCT07516405
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated
Contact us about this trial