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Taking people in United StatesPhase 2

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

Key facts

Who runs it
Carolyn Rodriguez
Where
Palo Alto, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
40 people, planned
Started
10 Sept 2025
Expected to end
1 Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • 3,4-Methyl enedioxy methamphetamine
  • Methamphetamine
  • Cognitive Behavioral Therapy (CBT)
Record updated
5 March 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 in United States

  • Stanford University Medical CenterPalo Alto, United StatesContact: Alessa Gaeta, BSTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • MDMA-assisted cognitive behavioral therapyTreatment being tested

    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).

    Treatment: 3,4-Methyl enedioxy methamphetamine and Cognitive Behavioral Therapy (CBT)

  • Methamphetamine-assisted cognitive behavioral therapyExisting treatment, for comparison

    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).

    Treatment: Methamphetamine and Cognitive Behavioral Therapy (CBT)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
MDMA-Assisted Cognitive Behavioral Therapy (CBT) Compared With Methamphetamine-Assisted CBT in Obsessive-Compulsive Disorder (OCD): A Phase II Study
Record updated
5 March 2026