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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-10

Study Completion Date

2026-12-01

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).

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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.

Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized with a 1:1 allocation to either MDMA-assisted CBT or methamphetamine-assisted CBT (active control).

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MDMA-assisted cognitive behavioral therapy

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).

Group Type EXPERIMENTAL

3,4-Methyl enedioxy methamphetamine

Intervention Type DRUG

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

Cognitive Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy with exposure and response prevention performed by therapist team.

Methamphetamine-assisted cognitive behavioral therapy

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).

Group Type ACTIVE_COMPARATOR

Methamphetamine

Intervention Type DRUG

Methamphetamine is a stimulant that affects the central nervous system. This is used as a control in the study.

Cognitive Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy with exposure and response prevention performed by therapist team.

Interventions

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3,4-Methyl enedioxy methamphetamine

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

Intervention Type DRUG

Methamphetamine

Methamphetamine is a stimulant that affects the central nervous system. This is used as a control in the study.

Intervention Type DRUG

Cognitive Behavioral Therapy (CBT)

Cognitive Behavioral Therapy with exposure and response prevention performed by therapist team.

Intervention Type BEHAVIORAL

Other Intervention Names

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MDMA MA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No