NCT05783817

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Carolyn Rodriguez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obsessive-Compulsive Disorder

Interventions

Type	Name	Description
DRUG	3,4-Methyl enedioxy methamphetamine	MDMA (3,4 methylenedioxymethamphetamine) is a synthetic, psychoactive drug that is chemically similar to the stimulant methamphetamine.
DRUG	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.

Timeline

• Start date: 2025-09-10
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-03-24
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study