Actively Recruiting
Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events
Led by Sheba Medical Center · Updated on 2026-03-13
168
Participants Needed
2
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years old
- Meet DSM-5 criteria for current PTSD diagnosed after October 7, 2023
- Have moderate or greater PTSD symptoms with a PCL-5 score of 36 or higher in the past month
- Be fluent in Hebrew (speaking and reading)
- Be able to swallow pills
- Be in psychotherapy prior to the study and agree to continue if still in therapy
- Provide a contact person who can be reached if participant becomes suicidal or unreachable
- Agree to inform investigators within 48 hours of any new medical conditions or procedures
- Agree to lifestyle modifications including fasting before sessions, no other clinical trial participation, overnight stays after sessions, and adherence to dosing and therapy
- If able to become pregnant, have a negative pregnancy test before each session and use effective birth control through 10 days after last session
- Have a permanent address for the next 6 months
- May have well-controlled hypertension with additional screening
- May have asymptomatic Hepatitis C previously evaluated and treated
- May have alcohol or substance use disorder if not withdrawing and with an agreed plan to reduce use
- May have stable type 2 diabetes with approval
- May have hypothyroidism with stable thyroid medication
- May have glaucoma with ophthalmologist approval
You will not qualify if you...
- Unable to give informed consent
- Allergic or sensitive to study interventions or components
- Active military duty expected in next 12 months
- Death of a close person within past 6 months
- Received Electroconvulsive Therapy, Transcranial Magnetic Stimulation, or Ketamine Therapy within 12 weeks
- History or current diagnosis of schizophrenia, schizoaffective disorder, psychotic major depression, bipolar disorder I or II, or dissociative identity disorder
- Current substance use disorder other than caffeine or nicotine that poses safety concerns or interferes with therapy
- Active illicit or prescription drug use disorder within 12 months except cannabis
- Current personality disorders in clusters A, B, or C
- Serious suicide risk or recent suicidal behavior within past 6 months
- Risk to others based on clinical interview
- Blood or needle phobia interfering with blood draws
- Immediate family member with psychotic disorder known to participant
- Medical conditions increasing risk from sympathomimetic drugs (e.g., heart attack, stroke, aneurysm)
- Uncontrolled high blood pressure
- History of serious arrhythmias or specific heart conduction disorders
- Prolonged QT/QTc interval or risk factors for Torsade de pointes
- Use of medications that prolong QT/QTc during sessions
- Symptomatic liver disease or significant liver enzyme elevations
- History of hyponatremia or hyperthermia
- Weigh less than 48 kg
- Received ketamine therapy or used ketamine within 12 weeks before enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Mental Health Medical Center Beer Sheva
Beersheba, Israel
Actively Recruiting
2
Lev-Hasharon Mental Health Medical Center
Pardesiyya, Israel
Actively Recruiting
Research Team
R
Revital Amiaz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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