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RECRUITING
NCT06233344
PHASE2

Mindfulness-assisted Psychedelic Therapy

Sponsor: University of Southern California

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test psilocybin in combination with mindfulness training in healthy adults. The main question it aims to answer is "Does mindfulness training enhance the effects of psychedelic therapy (psilocybin) on mental health?" Interested individuals will complete an initial eligibility session and eligible participants will then be randomized into one of two groups: one dose of psilocybin (administered under the supervision of study therapists) combined with 8 weeks of weekly mindfulness training classes (Arm 1) or psilocybin alone (Arm 2). Both groups will complete baseline and post-treatment assessment sessions where they will complete questionnaires, computerized cognitive tests, and have an EEG (a measure of electrical activity in the brain). Both groups will also complete 2 follow-up surveys (at 8 weeks and 1 year after the post-treatment assessment) either online through REDCap or by phone or video call with a research assistant.

Official title: An Exploratory Study of Feasibility, Efficacy, and Mechanisms of Mindfulness-Assisted Psychedelic Therapy

Key Details

Gender

All

Age Range

25 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-07-30

Completion Date

2027-08

Last Updated

2025-09-26

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Psilocybin plus mindfulness training

Participants will receive a single 25 mg dose of psilocybin under the supervision of study therapists. The psilocybin dosing session will take place approximately halfway through an 8-week mindfulness training course. The mindfulness training course will consist of weekly 2-hour classes with experienced mindfulness teachers; participants will be encouraged to practice mindfulness for 45 minutes per day between classes.

DRUG

Psilocybin

Participants will receive a single 25 mg dose of psilocybin under the supervision of study therapists.

Locations (1)

Univeristy of Southern California Brain and Creativity Institute

Los Angeles, California, United States