Preliminary Effectiveness of Individual and Group MDMA-assisted Therapy for Israeli Veterans With PTSD and Moral Injury.

The overall objective of this study is to use standard clinical measures to explore the safety and preliminary effectiveness of open-label MDMA-assisted therapy with a flexible dose of methylenedioxymethamphetaminel, in participants with Post traumatic Stress Disorder and moral injury, in individual and group treatment settings. The overall safety objective is to assess the severity, incidence, and frequency of AEs, AEs of Special Interest (AESIs), and Serious Adverse Events (SAEs), concomitant medication use, suicidal ideation and behavior and vital signs .

NCT Number	NCT05732155
Lead Sponsor	HaEmek Medical Center, Israel Collaborators: MAPS Public Benefit Corporation (MAPS PBC) 3141 Stevens Creek Blvd, #40547 San Jose, CA 95117 USA
Conditions	Post Traumatic Stress Disorder, Moral Injury, MDMA ('Ecstasy')
Enrollment	60 participants
Start Date	2023-06-01
Primary Completion	2027-06-01 (estimated)
Study Completion	2028-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-08