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

This Phase II interventional trial (n=40) aims to assess the safety and preliminary effectiveness of MDMA-assisted (80-120mg) cognitive behavioural therapy in participants diagnosed with obsessive-compulsive disorder (OCD).

Conducted by Carolyn Rodriguez at Stanford University, the study commenced in December 2023 and is estimated to complete in December 2026. The trial involves a randomised, double-blind, controlled design, with an estimated enrollment of 40 participants. Participants will be randomly assigned to either MDMA-assisted cognitive behavioral therapy or methamphetamine-assisted cognitive behavioral therapy (active control).

The intervention includes administering 80mg MDMA HCl (with a supplemental dose offered later) or 10mg methamphetamine (with a supplemental dose offered later) in combination with cognitive behavioral therapy (CBT). CBT involves exposure and response prevention performed by a therapist team.

The primary outcome measure is the change in the severity of OCD symptoms, assessed by the Yale-Brown Obsessive Compulsive Scale (YBOCS). The YBOCS measures obsessions and compulsions, with response defined as at least a 35% reduction in the YBOCS score. The study is estimated to conclude in December 2026.

Topic Obsessive-Compulsive Disorder
Compound MDMA
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 December 2023
End date 01 December 2026
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 40
Sex All
Age 17- 99
Therapy Yes

Trial Details

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.

NCT Number NCT05783817

Sponsors & Collaborators

Stanford University
Researchers at Stanford are exploring the potential of ketamine, MDMA and psilocybin by connecting neuroscience, psychiatry and anesthesiology.

Data attribution

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