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

Phase 2RecruitingNCT05783817

Carolyn Rodriguez40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obsessive-Compulsive Disorder

Interventions

3,4-Methyl enedioxy methamphetamineDRUG

MDMA (3,4 methylenedioxymethamphetamine) is a synthetic, psychoactive drug that is chemically similar to the stimulant methamphetamine.

MethamphetamineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University Medical Center

Palo Alto, California, United States

RECRUITING

Outcomes

Primary Outcomes

Chnage in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)

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.

Time frame: Baseline (Visit 1) to End of Intervention (Visit 13), up to 2 weeks

Central Contacts

Alessa Gaeta, MS

CONTACT

650-723-4095 ocdresearch@stanford.edu

Data from ClinicalTrials.gov

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