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.

Conducted at HaEmek Medical Center, Israel, the study involves administering a flexible dose of methylenedioxymethamphetamine (MDMA) in individual and group treatment settings. Therapy teams trained by MAPS PBC will conduct the study with at least 30 participants, with the treatment period lasting approximately 18 weeks.

Participants will undergo three monthly experimental sessions, including two individual sessions and one group session, followed by integrative sessions of non-drug psychotherapy. The primary outcome measure is the change in PTSD Checklist for DSM-5 (PCL-5) scores from baseline to the final outcome visit, approximately 35 weeks post-baseline. The study aims to assess the safety, incidence, and frequency of adverse events, as well as the preliminary effectiveness of MDMA-assisted therapy in this population.

Topic PTSD
Compound MDMA
Country Israel
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 June 2023
End date 01 December 2024
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 60
Sex All
Age 18- 99
Therapy Yes

Trial Details

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

Sponsors & Collaborators

HaEmek Medical Center
HaEmek Medical Center, located in Afula, Israel, is a district general and teaching hospital affiliated with the Rappaport Faculty of Medicine. It was established on April 29, 1930, and has grown to serve about 700,000 residents in its region.

Data attribution

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