RecruitingPhase 2NCT07469098

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


Sponsor

Sheba Medical Center

Enrollment

168 participants

Start Date

Dec 24, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing group therapy versus individual therapy, both combined with MDMA (commonly known as ecstasy), for treating PTSD in people affected by the October 7, 2023 attacks in Israel. The goal is to find out whether group or one-on-one sessions work better for trauma recovery. **You may be eligible if...** - You are at least 18 years old - You have a current PTSD diagnosis linked to the October 7, 2023 events or what followed - You have moderate to severe PTSD symptoms (score of 36 or higher on a standard checklist) - You are fluent in Hebrew - You were in some form of psychotherapy before the study - You have a support person (friend or family member) who can be contacted in an emergency - You have a stable address for the next 6 months **You may NOT be eligible if...** - You have a history of schizophrenia, bipolar disorder, or dissociative identity disorder - You currently have serious suicidal thoughts or a recent suicide attempt (within the last 6 months) - You have uncontrolled high blood pressure or a history of heart attack, stroke, or dangerous heart rhythms - You have a severe substance use disorder - You have lost a close person in the past 6 months - You are expected to be on active military duty in the next 12 months - You weigh less than 48 kg Talk to your doctor to see if this trial is right for you.

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

DRUGMDMA HCl

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)

Mental Health Medical Center Beer Sheva

Beersheba, Israel

Lev-Hasharon Mental Health Medical Center

Pardesiyya, Israel

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NCT07469098


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