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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Stanford University Medical Center
RECRUITING
Palo Alto
Contact Information
Primary
Pavithra Mukunda, MS
ocdresearch@stanford.edu
650-723-4095
Time Frame
Start Date: 2025-09-10
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 40
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Carolyn Rodriguez

This content was sourced from clinicaltrials.gov

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