Clinical trial NCT05783817: MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study)
Official title: MDMA-Assisted Cognitive Behavioral Therapy (CBT) Compared With Methamphetamine-Assisted CBT in Obsessive-Compulsive Disorder (OCD): A Phase II Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
MDMA
OCD CBT
Cognitive Behavioral Therapy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized with a 1:1 allocation to either MDMA-assisted CBT or methamphetamine-assisted CBT (active control).
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chnage in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Baseline (Visit 1) to End of Intervention (Visit 13), up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Carolyn Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.