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

Sponsor

Carolyn Rodriguez (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05783817

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder	Drug: 3,4-Methyl enedioxy methamphetamine Drug: Methamphetamine Behavioral: Cognitive Behavioral Therapy (CBT)	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 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).

Drug: 3,4-Methyl enedioxy methamphetamine

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

Other Names:

MDMA

Behavioral: Cognitive Behavioral Therapy (CBT)

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

Active Comparator: 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).

Drug: Methamphetamine

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

Other Names:

Behavioral: Cognitive Behavioral Therapy (CBT)

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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