Clinical TrialObsessive-Compulsive Disorder (OCD)MDMAPlaceboRecruiting

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

This PhaseII interventional trial (n=40), titled “MDMA-Assisted Cognitive Behavioral Therapy (CBT) Compared With Methamphetamine-Assisted CBT in Obsessive-Compulsive Disorder (OCD): A Phase II Study,” aims to assess the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive disorder (OCD).

Target Enrollment
40 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, parallel-group Phase II trial comparing MDMA-assisted CBT (80 mg with optional 40 mg supplemental dose 1.5–2 h later) versus methamphetamine-assisted CBT (10 mg with optional 5 mg supplemental) in adults with moderate–severe OCD (Y-BOCS ≥16).

Primary purpose is treatment; outcomes include safety, tolerability, and preliminary effectiveness on OCD symptoms alongside therapist-delivered CBT with exposure and response prevention.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

MDMA-assisted CBT

experimental

80 mg MDMA HCl with optional 40 mg supplemental dose 1.5–2 hours later, combined with CBT (exposure and response prevention).

Interventions

  • MDMA80 mg
    via Oral• single dose

    Supplemental 40 mg offered 1.5–2 h later.

Methamphetamine-assisted CBT

active comparator

10 mg methamphetamine with optional 5 mg supplemental dose 1.5–2 hours later, combined with CBT (exposure and response prevention).

Interventions

  • Placebo10 mg
    via Oral• single dose

    Methamphetamine 10 mg (5 mg supplemental 1.5–2 h later) encoded as active comparator in notes.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion 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

  • 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

Study Details

Locations

Stanford University Medical Center — Palo Alto, California, United States

Your Library