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