This study is a Phase 2, randomized, double-blind, active-controlled, two-arm, single-site clinical trial designed to evaluate the safety, tolerability, and feasibility of MDMA-Assisted Therapy (MDMA-AT) for Service Members (Active Duty, Guard, or Reserve) diagnosed with moderate-to-severe Post-Traumatic Stress Disorder (PTSD) within a Military Health System (MHS) setting.
The trial incorporates Acceptance and Commitment Therapy (ACT) as a core therapeutic modality. Participants will receive MDMA-AT utilizing either full-dose or active-control low-dose MDMA. The trial will also assess a regional referral center model by recruiting participants locally from the National Capital Region and non-locally across the MHS.
Positive endorsement of at least 1 index trauma on the LEC-5.
Have a PCL-5 total score of 38 or greater at screening.
Meet DSM-5-TR criteria for current PTSD per Mini International Neuropsychiatric Interview (MINI) at screening with a symptom duration of 6 months or longer.
Meet criteria for PTSD diagnosis per CAPS-5-R with a score of 26 or greater.
History of or current primary psychotic disorder to include Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder 1 assessed via MINI or clinical evaluation.
Current Major Depressive Disorder with Psychotic Features assessed via MINI or clinical evaluation.
Current eating disorder with active purging assessed via MINI or clinical evaluation.
Current Borderline Personality Disorder assessed via SCID-5-PD or clinical evaluation.
U.S. Army Medical Research and Development Command
Lead sponsor
Resilient Pharmaceuticals
Collaborator
Walter Reed National Military Medical Center
Collaborator
Congressionally Directed Medical Research Programs
Collaborator