Actively Recruiting
Mindfulness-assisted Psychedelic Therapy
Led by University of Southern California · Updated on 2025-09-26
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mindfulness-assisted Psychedelic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 25 years or older
- No prior formal mindfulness or meditation training
- No previous use of classic psychedelics
- Agree to consume usual caffeine amount or abstain on drug session day
- Agree to avoid psychoactive drugs, alcohol, and nicotine 24 hours before drug administration (except caffeine)
- Agree not to take PRN medications on drug session mornings
- Agree to avoid sildenafil, tadalafil, or similar medications within 72 hours of psilocybin
- Agree to refrain from nonprescription medications, nutritional or herbal supplements one week before drug session except approved exceptions
You will not qualify if you...
- Prior formal mindfulness or meditation training
- Previous use of psilocybin or other psychedelic drugs (LSD, mescaline, DMT/ayahuasca, 5-methoxy-DMT)
- Current use of serotonin system modulators or psychoactive prescription medications regularly
- Current or past history of schizophrenia, psychotic disorders, bipolar I or II, or close family with these disorders
- Recent or current history of alcohol or drug dependence or major depressive episode
- Suicidal ideation or behavior within specified recent periods
- Risky alcohol use in past two weeks
- Current obsessive-compulsive disorder, dysthymic disorder, panic disorder, dissociative disorder, anorexia nervosa, or bulimia nervosa
- Psychiatric conditions incompatible with safe psilocybin exposure
- Use or positive test for certain illicit drugs at screening or psilocybin visit
- Positive breath alcohol test at screening or psilocybin visit
- Pregnancy, planned pregnancy, breastfeeding, or unwillingness to use effective birth control
- Cardiovascular conditions such as coronary artery disease, stroke, angina, uncontrolled hypertension, ECG abnormalities, or recent TIA
- History of epilepsy with seizures
- Unstable medical conditions or diabetes with insulin dependence
- Any medical condition incompatible with safe psilocybin exposure
- Inability to speak English or provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Univeristy of Southern California Brain and Creativity Institute
Los Angeles, California, United States, 90089
Actively Recruiting
Research Team
B
Baruch R Cahn, MD, PhD
CONTACT
M
Mary Falcone, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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