MDMA-assisted cognitive behavioral therapy for obsessive-compulsive disorder
MDMA-Assisted Cognitive Behavioral Therapy (CBT) Compared With Methamphetamine-Assisted CBT in Obsessive-Compulsive Disorder (OCD): A Phase II Study
This trial will test whether MDMA combined with cognitive behavioral therapy can help adults with OCD have fewer symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05783817 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) with diagnosed OCD and Y-BOCS ≥16 who have failed at least one first-line treatment, can tolerate a medication-free period of about one month, are not pregnant or breastfeeding, weigh at least 48 kg, and can attend in-person visits at Stanford.
Not a fit: People who are pregnant or nursing, unable to stop psychotropic medications, weigh under 48 kg, or cannot travel to the study site are unlikely to qualify or benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could offer a new treatment option that reduces OCD symptoms and helps people who have not responded to standard therapies.
How similar studies have performed: MDMA-assisted psychotherapy has produced strong positive results in PTSD trials and small pilot studies, but applying MDMA specifically to OCD is a novel approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Palo Alto, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.