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

Carolyn Rodriguez

Status and phase: Not yet enrolling; Phase 2

Conditions: Obsessive-Compulsive Disorder

Treatments: Drug: 3,4-Methyl enedioxy methamphetamine; Drug: Methamphetamine; Behavioral: Cognitive Behavioral Therapy (CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05783817

66547

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

MDMA-assisted cognitive behavioral therapy

Experimental group

Description:

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).

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

Drug: 3,4-Methyl enedioxy methamphetamine

Methamphetamine-assisted cognitive behavioral therapy

Active Comparator group

Description:

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).

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

Drug: Methamphetamine