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Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

NCT07516405 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-11

No results posted yet for this study

Summary

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

Conditions

  • Healthy Volunteer
  • Older Adults (65-85 Years)

Interventions

DRUG

Psilocybin (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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-03-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07516405 on ClinicalTrials.gov