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

Obsessive-Compulsive Disorder Clinical Trial

— MDMA-CBT4OCD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05783817
• Other study ID #: 66547
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Pavithra Mukunda, MS
• Phone: 650-723-4095
• Email: ocdresearch[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Drug:
• 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.

Behavioral:
• Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy with exposure and response prevention performed by therapist team.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carolyn Rodriguez

References & 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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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