RecruitingPhase 1psilocybin

Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

Sponsored by University of Colorado, Denver

NCT ID
NCT07516405
Target Enrollment
40 participants
Start Date
2026-04-01
Est. Completion
2028-03

About This Study

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

Conditions Studied

Healthy VolunteerOlder Adults (65-85 Years)

Interventions

  • Psilocybin (Usona Institute)

Eligibility

Age:65 Years - 85 Years
Healthy Volunteers:Yes
View full eligibility criteria
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 Locations (6)

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

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Mary P Mancuso, MA (dual degrees)
CONTACT
3037245729inspire@cuanschutz.edu
Lila Harris, BS
CONTACT
lila.m.harris@cuanschutz.edu
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source