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

Phase 2

Not yet recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Drug: 3,4-Methyl enedioxy methamphetamine; Drug: Methamphetamine; Behavioral: Cognitive Behavioral Therapy (CBT)

• Registration Number: NCT05783817
• Lead Sponsor: Carolyn Rodriguez

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25
• Study Start: 2025-04-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MDMA-assisted cognitive behavioral therapy	3,4-Methyl enedioxy methamphetamine	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).
MDMA-assisted cognitive behavioral therapy	Cognitive Behavioral Therapy (CBT)	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).
Methamphetamine-assisted cognitive behavioral therapy	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).
Methamphetamine-assisted cognitive behavioral therapy	Methamphetamine	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).

Primary Outcome Measures

Name	Time	Method
Chnage in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)	Baseline (Visit 1) to End of Intervention (Visit 13), up to 2 weeks	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.