This PhaseII interventional trial (n=40), titled “MDMA-Assisted Cognitive Behavioral Therapy (CBT) Compared With Methamphetamine-Assisted CBT in Obsessive-Compulsive Disorder (OCD): A Phase II Study,” aims to assess the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive disorder (OCD).
Randomised, parallel-group Phase II trial comparing MDMA-assisted CBT (80 mg with optional 40 mg supplemental dose 1.5–2 h later) versus methamphetamine-assisted CBT (10 mg with optional 5 mg supplemental) in adults with moderate–severe OCD (Y-BOCS ≥16).
Primary purpose is treatment; outcomes include safety, tolerability, and preliminary effectiveness on OCD symptoms alongside therapist-delivered CBT with exposure and response prevention.
80 mg MDMA HCl with optional 40 mg supplemental dose 1.5–2 hours later, combined with CBT (exposure and response prevention).
Supplemental 40 mg offered 1.5–2 h later.
10 mg methamphetamine with optional 5 mg supplemental dose 1.5–2 hours later, combined with CBT (exposure and response prevention).
Methamphetamine 10 mg (5 mg supplemental 1.5–2 h later) encoded as active comparator in notes.