Mindfulness-assisted Psychedelic Therapy

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT06233344
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mental Health

Eligibility Criteria

Sex
ALL
Age
25 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Psilocybin plus mindfulness training — DRUG
    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.
  • Psilocybin — DRUG
    Participants will receive a single 25 mg dose of psilocybin under the supervision of study therapists.

Study Details

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.

Key Dates

Start date
Jul 30, 2025
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Mindfulness-assisted psilocybin therapy
    8 weeks of mindfulness training plus one 25mg dose of psilocybin
  • Active Comparator: Psilocybin only
    One 25mg dose of psilocybin

Primary Outcome Measure

Retention at 8-week follow-up [ Time Frame: 8-week follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Univeristy of Southern California Brain and Creativity InstituteLos AngelesCalifornia90089
Rael Cahn, MD, PhD
[email protected]
213-764-4871
Baruch R Cahn, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Univeristy of Southern California Brain and Creativity Institute· Los Angeles, CA

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