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

Overview

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

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: December 1, 2026

Detailed Description

Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. The proposed projects tests whether 3,4-Methylenedioxymethamphetamine (MDMA) reduces OCD symptoms.

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.

Arms, Groups and Cohorts

• 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).

Clinical Trial Outcome Measures

Primary 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Carolyn Rodriguez
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Carolyn Rodriguez, Professor – Stanford University
• Overall Official(s)
  • Carolyn Rodriguez, MD, PhD, Principal Investigator, Stanford University
• Overall Contact(s)
  • Pavithra Mukunda, MS, 650-723-4095, ocdresearch@stanford.edu

Citations Reporting on Results

Mitchell JM, Bogenschutz M, Lilienstein A, Harrison C, Kleiman S, Parker-Guilbert K, Ot'alora G M, Garas W, Paleos C, Gorman I, Nicholas C, Mithoefer M, Carlin S, Poulter B, Mithoefer A, Quevedo S, Wells G, Klaire SS, van der Kolk B, Tzarfaty K, Amiaz R, Worthy R, Shannon S, Woolley JD, Marta C, Gelfand Y, Hapke E, Amar S, Wallach Y, Brown R, Hamilton S, Wang JB, Coker A, Matthews R, de Boer A, Yazar-Klosinski B, Emerson A, Doblin R. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021 Jun;27(6):1025-1033. doi: 10.1038/s41591-021-01336-3. Epub 2021 May 10.