Recruiting
Phase 2

MDMA with CBT

Sponsor:

Carolyn Rodriguez

Code:

NCT05783817

Conditions

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3,4-Methyl enedioxy methamphetamine

Methamphetamine

Cognitive Behavioral Therapy (CBT)

Study Details

Brief summary:

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

Conditions

Obsessive-Compulsive Disorder

Study ID

NCT05783817

Start date

Sep 10, 2025

Status verified date

Mar, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. At least 18 years old
2. Fluent in speaking and reading the predominantly used or recognized language of the study site
3. Able to swallow pills
4. Meet the criteria for OCD diagnosis
5. YBOCS total score of at least 16
6. Not on psychotropic medications 1 month prior to study enrollment
7. Able to tolerate a treatment-free period
8. Able to tolerate study procedures
9. Failed at least 1 prior trial of standard first-line OCD treatment
10. 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:

1. Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control
2. Weigh less than 48 kilograms (kgs)
3. Any current problem which, in the opinion of the investigator or study physician, might interfere with participation

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MDMA-assisted cognitive behavioral therapy

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).

active comparator: Methamphetamine-assisted cognitive behavioral therapy

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).

Interventions

3,4-Methyl enedioxy methamphetamine

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

Methamphetamine

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

Cognitive Behavioral Therapy (CBT)

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Alessa Gaeta, MS

650-723-4095ocdresearch@stanford.edu

Locations

Stanford University Medical Center

Recruiting

Palo Alto, California, United States, 94305

Contacts

Alessa Gaeta, BS

650-723-4095ocdresearch@stanford.edu

More Information

Sponsor

Carolyn Rodriguez

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • OCD
  • MDMA
  • OCD CBT
  • Cognitive Behavioral Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carolyn Rodriguez on 2026-03-05.