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Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
Sheba Medical Center
49 trials monitored
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PTSD
889 trials monitored
See 54 trials at risk
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).
Trial Details
NCT Number NCT07469098
Lead Sponsor Sheba Medical Center
Conditions
(from sponsor)		 PTSD
Related terms Stress Disorders, Post-Traumatic
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov