Psilocybin + Mindfulness for Mental Health
(MAPT Trial)
Trial Summary
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial excludes participants who are currently using specific medications like antidepressants, antipsychotics, and others that affect the serotonin system. If you use these medications intermittently, there must be a gap of at least 5 half-lives of the medication before participating in a psilocybin session.
What data supports the effectiveness of the treatment Mindfulness-assisted Psychedelic Therapy for mental health?
Research suggests that combining psilocybin (a psychedelic drug) with mindfulness practices can enhance mood, increase mindfulness, and improve social skills. Studies show that psilocybin can lead to long-term positive changes in personality and psychological functioning, especially when combined with meditation or spiritual practices.12345
Is psilocybin combined with mindfulness safe for mental health treatment?
Psilocybin, when used in a controlled and supportive environment, is generally considered safe, with most people finding the experience positive. Some may experience challenging moments, but these are usually manageable with support. Psilocybin can cause temporary increases in blood pressure, but no long-term negative effects have been reported in well-prepared participants.46789
How is Mindfulness-assisted Psychedelic Therapy different from other treatments for mental health?
Mindfulness-assisted Psychedelic Therapy combines mindfulness meditation with psilocybin, a psychedelic, to potentially enhance the therapeutic effects of both. This unique combination may improve mental health by altering present-moment awareness and providing antidepressant effects, which are not typically achieved with standard treatments.110111213
What is the purpose of this trial?
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 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.
Research Team
Baruch R Cahn, MD, PhD
Principal Investigator
University of Southern California
Eligibility Criteria
This trial is for healthy adults interested in exploring the effects of psychedelic therapy on mental health. Participants must be eligible based on an initial session and willing to undergo psilocybin treatment under supervision, with or without mindfulness training. Details about specific inclusion and exclusion criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one dose of psilocybin, with Arm 1 also receiving 8 weeks of mindfulness training
Post-treatment Assessment
Participants complete questionnaires and cognitive assessments, including EEG
Follow-up
Participants complete follow-up surveys at 8 weeks and 1 year after post-treatment assessment
Treatment Details
Interventions
- Mindfulness-assisted Psychedelic Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor