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RecruitingPhase 2

MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study)

NCT05783817 · MDMA-CBT4OCD · Carolyn Rodriguez

Recruiting
Status
Accepting participants
Phase 2
Phase
40
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The study assesses the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive disorder (OCD).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Chnage in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)

    Measured over Baseline (Visit 1) to End of Intervention (Visit 13), up to 2 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
Stanford University Medical CenterPalo AltoCaliforniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05783817 on ClinicalTrials.gov →

Last updated in the registry 2026-03-05. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits