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

ConditionObsessive-Compulsive Disorder

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorCarolyn Rodriguez

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: MDMA-assisted cognitive behavioral therapyExperimental treatment 2 interventions

Group B: Methamphetamine-assisted cognitive behavioral therapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Baseline (Visit 1) to End of Intervention (Visit 13), up to 2 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carolyn Rodriguez

Lead sponsor

Stanford University

Sponsor institution

Source ClinicalTrials.gov

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