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

Last updated: March 3, 2026
Sponsor: Carolyn Rodriguez
Overall Status: Active - Recruiting

Phase

2

Condition

Obsessive-compulsive Disorder

Anxiety Disorders

Kleptomania

Treatment

Methamphetamine

3,4-Methyl enedioxy methamphetamine

Cognitive Behavioral Therapy (CBT)

Clinical Study ID

NCT05783817
66547
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At least 18 years old

  2. Fluent in speaking and reading the predominantly used or recognized language of thestudy 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 fastingand refraining from certain medications prior to the Experimental Session, notenroll in any other interventional clinical trials during the duration of the study,and commit to medication dosing, therapy, and study procedures.

Exclusion

Exclusion Criteria:

  1. Pregnant or nursing, or able to become pregnant and are not practicing an effectivemeans 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

Study Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: Methamphetamine
Phase: 2
Study Start date:
September 10, 2025
Estimated Completion Date:
December 01, 2026

Study Description

Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. The proposed projects tests whether 3,4-Methylenedioxymethamphetamine (MDMA) reduces OCD symptoms.

Connect with a study center

  • Stanford University Medical Center

    Palo Alto, California 94305
    United States

    Active - Recruiting

  • Stanford University Medical Center

    Palo Alto 5380748, California 5332921 94305
    United States

    Site Not Available

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