RecruitingPhase 1NCT07516405

Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

Sponsor

University of Colorado, Denver

Enrollment

40 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteer Older Adults (65-85 Years)

Summary

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

Eligibility

Min Age: 65 YearsMax Age: 85 Years

Inclusion Criteria4

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

Exclusion Criteria13

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

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Interventions

DRUGPsilocybin (Usona Institute)

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.