Preliminary Effectiveness of Individual and Group MDMA-assisted Therapy for Israeli Veterans With PTSD and Moral Injury
This open-label trial (n=30) aims to explore the safety and preliminary effectiveness of MDMA-assisted therapy in Israeli veterans with PTSD and moral injury from special forces undercover units.
Details
Single-site, open-label, non-randomised Phase II study of MDMA-assisted therapy in Israeli special-forces veterans with PTSD and moral injury, using manualised therapy delivered by MAPS-trained teams.
Participants receive a flexible dose of MDMA HCl in three experimental sessions (two individual, one group) across a ~17–18 week treatment period, preceded by three 90-minute preparatory sessions and followed by multiple 90-minute integration sessions; experimental sessions last ~8 hours with overnight stay.
Primary outcome is change in PCL-5 from baseline to ~35 weeks; safety assessments include AEs/AESIs/SAEs, vital signs, concomitant medications and suicidal ideation/behaviour monitoring.