Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events (NCT07469098) | Clinical Trial Compass
RecruitingPhase 2
Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events
Israel168 participantsStarted 2025-12-24
Plain-language 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Are at least 18 years old.
. At Screening, meet DSM-5 criteria for current PTSD that has been diagnosed past 7/10/23 and the events following.
. At Screening, have at least moderate PTSD symptoms in the last month, based on PCL-5 total score of 36 or greater, conducted by certified Study coordinators.
. Are fluent in speaking and reading the predominantly used or recognized language of the study site (Hebrew).
. Are able to swallow pills.
. Participant where in psychotherapy prior to the study. If the participant is still in psychotherapy during study enrollment, they consent to continue therapy during the study and provide consent for the investigator to communicate with the therapist as needed.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in PTSD symptoms as measured by CAPS-5
Timeframe: Baseline to end-of-treatment visit (Week 17 in the GMAT; Week 13 in the IMAT)
2
Change in PTSD symptoms as measured by PCL-5
Timeframe: Baseline to end-of-treatment visit (Week 17 in the GMAT; Week 13 in the IMAT)
. Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
Exclusion criteria
. Are not able to give adequate informed consent.
. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or study clinician, contraindicates participation in the study.
. Active military duty expected in the following 12 months.
. Death of a close person in the past 6 months.
. Have received Electroconvulsive Therapy, Transcranial Magnetic Stimulation, or Ketamine Therapy within 12 weeks of enrollment.
. Have a history of, or a current diagnosis of schizophrenia, schizoaffective disorder, major depressive disorder with psychotic features, psychotic disorder, bipolar disorder I or II (with or without psychotic features), or dissociative identity disorder assessed by medical history, investigator interview and the Mini-International Neuropsychiatric Interview (MINI).
. Have a current substance use disorder other than caffeine or nicotine that the investigators, therapy team, and/or study physician judge to be a safety concern for enrollment in the study or that could interfere with the therapeutic process or with other aspects of study participation as assessed by clinical interview per DSM-5 as well as Audit and Dudit questionnaires. Any participant who is not able to agree or adhere to a plan to reduce use and manage symptoms will not be enrolled.
. Have an active illicit (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment.