Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events
An Open-Label, Multicenter, Randomized, Non-Inferiority Study to Evaluate the Safety and Effectiveness of Group vs. Individual MDMA-Assisted Therapy in PTSD Patients Diagnosed Following the Events of October 7, 2023
Sheba Medical Center
168 participants
Dec 24, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to evaluate the safety, tolerability and effectiveness of group-based MDMA-assisted therapy compared to individual MDMA-assisted therapy in participants with PTSD, who were diagnosed following the events of 7 October 2023. The main questions it aims to answer are: safety and tolerability? effectiveness? Researchers will compare group-based MDMA-assisted therapy to individual MDMA-assisted therapy to see if group-based MDMA-assisted therapy is not inferior to individual MDMA-assisted therapy, in terms of safety and effectiveness. Participants will be randomized to one of two study arms: group-based MDMA-assisted therapy or individual MDMA-assisted therapy receive MDMA HCl administered orally in a divided dose. Participate in preparatory sessions, MDMA dosing sessions, and integration sessions. Be monitored for adverse events and suicidality (C-SSRS). Be monitored by an external Data Safety Monitoring Board (DSMB).
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
MDMA HCl will be administered orally during dosing sessions in a divided dose. In the first dosing session, participants will receive 80 mg MDMA HCl with a supplemental dose of 40 mg administered 1.5 to 2 hours after the initial dose. In the second and third dosing sessions, participants will receive 120 mg MDMA HCl with a supplemental dose of 60 mg administered 1.5 to 2 hours after the initial dose.
Locations(2)
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For the most up-to-date information, visit the official listing.
NCT07469098