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RecruitingPhase 1

Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

NCT07516405 · Psil-Pk · University of Colorado, Denver

Recruiting
Status
Accepting participants
Phase 1
Phase
40
Target enrolment
6
Study sites
6 US states

What it is testing

Summary

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Adverse Events

    Measured over up to 14 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

65 Years to 85 Years
Ages
All
Sex
Accepted
Healthy volunteers
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

Where

6 study sites

FacilityCityRegionCountry
University of California San Francisco (UCSF) Department of NeurologySan FranciscoCaliforniaUnited States
University of Colorado Anschutz Medical CampusAuroraColoradoUnited States
Emory University Brain Health CenterAtlantaGeorgiaUnited States
Dana-Farber Cancer InstituteBostonMassachusettsUnited States
University of Nebraska Medical CenterOmahaNebraskaUnited States
New York University Langone Health, Center for Psychedelic MedicineNew YorkNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07516405 on ClinicalTrials.gov →

Last updated in the registry 2026-08-10. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits