MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study)
Recruiting · NCT05783817 · Interventional (participants receive a specific treatment) · Lead sponsor: Carolyn Rodriguez
View the official record on ClinicalTrials.gov →Interventions studied
3,4-Methyl enedioxy methamphetamineCognitive Behavioral Therapy (CBT)Methamphetamine
What this trial is about
The study assesses the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive disorder (OCD).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Stanford University Medical Center - Palo Alto, California, United States