Exploring Mechanisms of Action in MDMA-Assisted Therapy for PTSD (MP8-S1)

Exploring Mechanisms of Action of 3,4-methylenedioxymethamphetamine (MDMA)- Assisted Psychotherapy for Posttraumatic Stress Disorder (PTSD)

This exploratory sub-study was designed to determine psychotherapeutic processes that may occur during MDMA-assisted therapy in people with chronic PTSD and assess the feasibility of exploring physiological correlates of clinical outcomes in participants enrolled in the parent study.

To support the clinical outcomes measured by CAPS from the MP8 study, the sponsor was interested in correlations of outcomes with treatment-related changes in potential biological markers of PTSD, measured by heart rate variability (HRV) and functional magnetic resonance imaging (fMRI). Brain activity was measured while listening to neutral and personalized trauma-related scripts at baseline and after Experimental Sessions of MDMA-assisted therapy with low, medium, or full dose MDMA.