MDMA for AUD/PTSD Comorbidity (MDMA)
This open-label, Phase II trial (n=18) will investigate the safety and preliminary effectiveness of MDMA-assisted therapy (MDMA-AT) in military veterans with co-occurring Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).
Details
Open-label single-group pilot (n=18) testing MDMA-assisted therapy in military veterans with comorbid AUD and PTSD. Participants receive two once-monthly experimental sessions of divided-dose MDMA HCl paired with preparatory and integrative psychotherapy delivered by clinicians trained by MAPS PBC.
Primary outcome is change in alcohol use measured by Timeline Follow-back (TLFB); PTSD symptoms (CAPS-5, PCL-5), neuroimaging and biomarker measures are collected pre- and post-treatment along with safety/tolerability assessments.