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

Not Recruiting

Trial ID: NCT05783817

Purpose

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

Official Title

MDMA-Assisted Cognitive Behavioral Therapy (CBT) Compared With Methamphetamine-Assisted CBT in Obsessive-Compulsive Disorder (OCD): A Phase II Study

Stanford Investigator(s)

Carolyn Rodriguez
Carolyn Rodriguez

Professor of Psychiatry and Behavioral Sciences (Public Mental Health and Population Sciences)

Eligibility


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

Intervention(s):

drug: 3,4-Methyl enedioxy methamphetamine

drug: Methamphetamine

behavioral: Cognitive Behavioral Therapy (CBT)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305