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

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

Detailed Description
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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.

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

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Drug: 3,4-Methyl enedioxy methamphetamine
* Drug: Methamphetamine
* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Fluent in speaking and reading the predominantly used or recognized language of the study site Able to swallow pills Meet the criteria for OCD diagnosis YBOCS total score of at least 16 Not on psychotropic medications 1 month prior to study enrollment Able to tolerate a treatment-free period Able to tolerate study procedures Failed at least 1 prior trial of standard first-line OCD treatment 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: Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control Weigh less than 48 kilograms (kgs) Any current problem which, in the opinion of the investigator or study physician, might interfere with participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized with a 1:1 allocation to either MDMA-assisted CBT or methamphetamine-assisted CBT (active control).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDMA-assisted cognitive behavioral therapy<br>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). | Drug: 3,4-Methyl enedioxy methamphetamine<br>* MDMA (3,4 methylenedioxymethamphetamine) is a synthetic, psychoactive drug that is chemically similar to the stimulant methamphetamine.<br>* Other names: MDMA;Behavioral: Cognitive Behavioral Therapy (CBT)<br>* Cognitive Behavioral Therapy with exposure and response prevention performed by therapist team.<br>|
| Active Comparator: Methamphetamine-assisted cognitive behavioral therapy<br>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). | Drug: Methamphetamine<br>* Methamphetamine is a stimulant that affects the central nervous system. This is used as a control in the study.<br>* Other names: MA;Behavioral: Cognitive Behavioral Therapy (CBT)<br>* Cognitive Behavioral Therapy with exposure and response prevention performed by therapist team.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Visit 1) to End of Intervention (Visit 13), up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDMA, OCD, OCD CBT, Cognitive Behavioral Therapy