Overview

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

Status:
Not yet recruiting

Trial end date:
2024-12-01

Target enrollment:

Participant gender:

Summary

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 .

Phase:

Phase 2

Details

Lead Sponsor:

HaEmek Medical Center, Israel

Collaborator:

MAPS Public Benefit Corporation (MAPS PBC) 3141 Stevens Creek Blvd, #40547 San Jose, CA 95117 USA

Treatments:

N-Methyl-3,4-methylenedioxyamphetamine