MDMA-assisted cognitive behavioral therapy for obsessive-compulsive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study tests 3,4-methylenedioxymethamphetamine (MDMA) given alongside structured cognitive behavioral therapy in adults with moderate-to-severe OCD. Participants must meet diagnostic criteria for OCD with a Y-BOCS score of at least 16, have failed at least one prior first-line treatment, and be off psychotropic medications for at least one month. Treatment involves supervised MDMA dosing sessions paired with CBT and regular safety monitoring, with symptom scales used to measure preliminary effectiveness. The trial is conducted in-person at Stanford University Medical Center with follow-up visits to track outcomes and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. At least 18 years old
2. Fluent in speaking and reading the predominantly used or recognized language of the study site
3. Able to swallow pills
4. Meet the criteria for OCD diagnosis
5. YBOCS total score of at least 16
6. Not on psychotropic medications 1 month prior to study enrollment
7. Able to tolerate a treatment-free period
8. Able to tolerate study procedures
9. Failed at least 1 prior trial of standard first-line OCD treatment
10. Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to the Experimental Session, not enroll in any other interventional clinical trials during the duration of the study, and commit to medication dosing, therapy, and study procedures.

Exclusion Criteria:

1. Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control
2. Weigh less than 48 kilograms (kgs)
3. Any current problem which, in the opinion of the investigator or study physician, might interfere with participation

Where it's running

• Stanford University Medical Center
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: Carolyn Rodriguez, MD, PhD — Stanford University
• Study coordinator: Alessa Gaeta, MS
• Email: ocdresearch@stanford.edu
• Phone: 650-723-4095

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.