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

MDMA

Brief Summary

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

Intervention / Treatment

Participants will be randomized with a 1:1 allocation to either MDMA-assisted CBT or methamphetamine-assisted CBT (active control).
  • 3,4-Methyl enedioxy methamphetamine (DRUG)
    MDMA (3,4 methylenedioxymethamphetamine) is a synthetic, psychoactive drug that is chemically similar to the stimulant methamphetamine.
  • Methamphetamine (DRUG)
    Methamphetamine is a stimulant that affects the central nervous system. This is used as a control in the study.
  • Cognitive Behavioral Therapy (CBT) (BEHAVIORAL)
    Cognitive Behavioral Therapy with exposure and response prevention performed by therapist team.

Condition or Disease

  • Obsessive-Compulsive Disorder

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Not yet recruiting
    Study results: No Results Available
    Enrollment: 40 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Dec 01, 2023 ESTIMATED
    Primary Completion: Dec 01, 2026 ESTIMATED
    Completion Date: Dec 01, 2026 ESTIMATED
    Study First Posted: Mar 24, 2023 ACTUAL
    Last Updated: Mar 28, 2023

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Responsible Party: N/A

    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.

    Participant Groups

    • Administration of 80mg MDMA HCl (with a supplemental dose offered 1.5 to 2 hours later of 40 mg MDMA HCl) in combination with cognitive behavioral therapy (CBT).

    • Administration of 10mg methamphetamine (with a supplemental dose offered 1.5 to 2 hours later of 5 mg methamphetamine) in combination with cognitive behavioral therapy (CBT).

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Change in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.

    More Details

    NCT Number: NCT05783817
    Other IDs: 66547
    Study URL: https://clinicaltrials.gov/study/NCT05783817
    Last updated: Sep 29, 2023