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

NCT05783817 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 66547
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

OCD; MDMA; OCD CBT; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• Chnage in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)

  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.

  Baseline (Visit 1) to End of Intervention (Visit 13), up to 2 weeks

Study Arms (2)

MDMA-assisted cognitive behavioral therapy

EXPERIMENTAL

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).

Drug: 3,4-Methyl enedioxy methamphetamine; Behavioral: Cognitive Behavioral Therapy (CBT)

Methamphetamine-assisted cognitive behavioral therapy

ACTIVE COMPARATOR

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).

Drug: Methamphetamine; Behavioral: Cognitive Behavioral Therapy (CBT)

Interventions

3,4-Methyl enedioxy methamphetamine DRUG

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

Also known as: MDMA

MDMA-assisted cognitive behavioral therapy

Methamphetamine DRUG

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

Also known as: MA

Methamphetamine-assisted cognitive behavioral therapy

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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

MDMA-assisted cognitive behavioral therapy; Methamphetamine-assisted cognitive behavioral therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Carolyn Rodriguez: lead

Study Sites (1)

Stanford University Medical Center

Palo Alto, California, 94305, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 33972795 RESULT

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Methamphetamine; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carolyn Rodriguez, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessa Gaeta, MS

CONTACT

650-723-4095; ocdresearch@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized with a 1:1 allocation to either MDMA-assisted CBT or methamphetamine-assisted CBT (active control).

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: September 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)