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NCT Number: NCT05783817

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location status: Recruiting

Location contact

Alessa Gaeta, BS

CONTACT

[email protected]

650-723-4095

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3,4-Methyl enedioxy methamphetamine

Drug

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

Other names: MDMA

Methamphetamine

Drug

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

Other names: MA

Cognitive Behavioral Therapy (CBT)

Behavioral

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

Primary outcomes

  1. Chnage in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessa Gaeta, MS

CONTACT

[email protected]

650-723-4095

Sponsors and collaborators

Lead sponsor

Carolyn Rodriguez

Other

Registry information

Official study title

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

Acronym: MDMA-CBT4OCD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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