NCT05783817 · Carolyn Rodriguez
MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study)
(MDMA-CBT4OCD)
What this study is about
The study assesses the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive disorder (OCD).
View original scientific description
The study assesses the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive disorder (OCD).
Interventions
DRUG
3,4-Methyl enedioxy methamphetamine
MDMA (3,4 methylenedioxymethamphetamine) is a synthetic, psychoactive drug that is chemically similar to the stimulant methamphetamine.
DRUG
Methamphetamine
Methamphetamine is a stimulant that affects the central nervous system. This is used as a control in the study.
BEHAVIORAL
Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy with exposure and response prevention performed by therapist team.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Palo Alto, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations