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Mindfulness-Assisted Psychedelic Therapy

Study acronym: MAPT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 2026 → Aug 2027
See other at-risk trials from University of Southern California

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 2026 to Aug 2027
    • Study completion pushed from Aug 2027 to Aug 2028
    • Study description revised
    • Site contact updated
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 8 more changesShow less
    • Primary completion date: Dec 2025 to Aug 2026
    • Start date changed from estimate of Jul 2024 to Jul 30, 2025
    • Primary endpoints: 3 to 2
    • Study completion date: Jul 2026 to Aug 2027
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 2 to 4
    • Study description expanded, about 10 words
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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) and functional MRI of brain if possible. 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.
Trial Details
NCT Number NCT06233344
Lead Sponsor University of Southern California
Conditions
(from sponsor)		 Mental Health
Related terms Psychological Well-Being
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov