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PTSDPhase 2NCT07469098

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

A Phase 2 study testing MDMA HCl in people with PTSD, run by Sheba Medical Center at 2 sites in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
PTSD
What is being tested?
MDMA HCl
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
2 sitesIsrael
Study dates
24 Dec 2025to 31 Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Agree to the following lifestyle modifications (see lifestyle modifications section) : comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures.
  • If able to become pregnant (i.e. assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom).
  • Holds a permanent address in the next 6 months.
  • Medical History
  • May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease.
  • May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
  • May have alcohol or substance use disorder if the participant is not in withdrawal or requiring detox. Participants must have a plan, agreed upon by the investigator, therapy team, and study physician, to reduce use of alcohol or other substances and to manage symptoms without self-medicating. Enrollment will require that, in the judgment of the investigator, therapy team, and study physician, the plan for decreasing substance use is realistic and has a good chance of succeeding in order to prevent substance use from impacting the safety or efficacy of the investigational treatment.
  • May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the study physician.
  • May have hypothyroidism if taking adequate and stable thyroid replacement medication.
  • May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.

Who cannot join

  • 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.
  • Psychiatric History
  • Have received Electroconvulsive Therapy, Transcranial Magnetic Stimulation, or Ketamine Therapy within 12 weeks of enrollment.
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  • 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.
  • Have current Personality Disorders Cluster A (paranoid, schizoid, schizotypal), Cluster B (antisocial, borderline, histrionic, narcissistic), or Cluster C (avoidant, dependent, obsessive-compulsive) assessed via SCID-5-PD.
  • Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to C-SSRS, and clinical judgment of the investigator will be excluded; however, history of suicide attempts is not an exclusion. Any participant who is likely to require hospitalization related to suicidal ideation and behavior, in the judgment of the investigator, will not be enrolled. Any participant presenting with the following on the Baseline C-SSRS will be excluded:
  • Suicidal ideation score of 4 or greater within the last 6 months of the assessment at a frequency of once a week or more.
  • Suicidal ideation score of 5 within the last 6 months of the assessment.
  • Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment. Participants with non-suicidal self-injurious behavior may be included if approved by the study physician.
  • Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.
  • Have a blood or needle phobia that interferes with obtaining necessary blood work.
  • Have an immediate family member diagnosed with a psychotic disorder to the participant's knowledge.
  • Medical History
  • Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, or aneurysm. Participants with other mild, stable chronic medical problems may be enrolled if the study physician and sponsor-investigator agree the condition would not significantly increase the risk of MDMA administration or be likely to produce significant symptoms during the study that could interfere with study participation or be confused with side effects of the use of MDMA. Examples of stable medical conditions that could be allowed include, but are not limited to Diabetes Mellitus (Type 2), Human Immunodeficiency Virus (HIV) infection, Gastroesophageal Reflux Disease (GERD), etc. Any medical disorder judged by the investigator to significantly increase the risk of MDMA administration by any mechanism would require exclusion.
  • Have uncontrolled essential hypertension using the standard criteria of the American Heart Association (values of 140/90 milligrams of Mercury [mmHg] or higher assessed on three separate occasions).
  • Have a history of ventricular arrhythmia at any time, other than premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
  • Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
  • Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening. Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs and confirmed by a cardiologist.
  • Have a marked Baseline prolongation of QT/QTc interval e.g., repeated demonstration of a QTc interval > 450 milliseconds (ms) in males and >460 ms in females corrected using Fridericia's formula. For transgender or non-binary participants, QTc interval will be evaluated based on sex assigned at birth, unless the participant has been on hormonal treatment for 5 or more years.
  • Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
  • Require use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions. Refer to protocol section on Concomitant Medications.
  • Have symptomatic liver disease or have significant liver enzyme elevations.
  • Have history of hyponatremia or hyperthermia.
  • Weigh less than 48 kilograms (kg).
  • Have engaged in ketamine-assisted therapy or used ketamine within 12 weeks of enrollment.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Revital Amiaz contact

972542378757

revital.amiaz@sheba.health.gov.il

Israel2 sites, 2 recruiting

  • Mental Health Medical Center Beer Sheva

    Beersheba

    Oded Arbel

    Recruiting

  • Lev-Hasharon Mental Health Medical Center

    Pardesiyya

    Kfir Feffer

    Recruiting

Other trials in Israel

About this study

Official title: 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

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).

Read the detailed description

PTSD (post-traumatic stress disorder) is a severe and debilitating disorder that may occur following a traumatic event, with significant consequences on daily life, such as inability to form beneficial relationships, inability to maintain employment, reduced cognitive and psycho-social functioning, depression, anxiety and alcohol disorders and use of addictive substances. Available PTSD treatments include medications and therapy, but they effectively treat only a small portion of people, indicating a need to develop treatments targeting durable remission of PTSD.

MDMA is a phenylisopropylamine derivative. MDMA increases levels of serotonin and also increases levels of oxytocin and vasopressin, which are associated with increased trust and reduced reactivity to threatening situations. MDMA is not used as a treatment by itself, but as an adjunct that enhances the effectiveness of psychotherapy.

Participants will complete pre-screening. Screening and enrollment procedures include review of medical and psychiatric history, documentation of prior/current medications, and completion of questionnaires. Participants will be asked to complete questionnaires throughout the study, including during screening and at multiple time points across study visits, to assess symptoms and other study-related measures. Eligible participants will be randomized, with allocation managed centrally, to one of two treatment arms.

Prior to administration of the investigational product, participants will attend preparatory sessions. MDMA HCl will be administered orally in a divided dose, with a supplemental dose administered 1.5 to 2 hours after the initial dose. During dosing sessions, participants will be monitored, including measurement of vital signs by trained medical staff. Safety procedures include physical examination, urine drug testing, ECG assessment, and safety laboratory tests as specified in the protocol.

Safety monitoring will include assessment of adverse events and C-SSRS. Study safety will be overseen by an external Data Safety Monitoring Board (DSMB).

Conditions
PTSD
Being tested
MDMA HCl
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDMA HClDrug

    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.

Study groups in NCT07469098
Study groupRoleWhat they receive
Group-based MDMA-assisted therapyExperimentalParticipants will receive group-based MDMA-assisted therapy (up to 7 participants per group). Each group will include participants with the same type of trauma. MDMA HCl will be administered orally during dosing sessions in a divided dose, with a supplemental dose administered 1.5 to 2 hours after the initial dose. Participants will attend preparatory sessions and integration sessions according to the protocol.
Receives: Drug: MDMA HCl
Individual MDMA-assisted therapyExperimentalParticipants will receive individual MDMA-assisted therapy. MDMA HCl will be administered orally during dosing sessions in a divided dose, with a supplemental dose administered 1.5 to 2 hours after the initial dose. Participants will attend preparatory sessions and integration sessions according to the protocol.
Receives: Drug: MDMA HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in PTSD symptoms as measured by CAPS-5

    Change from baseline in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).

    Measured: 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

    Change from baseline in PTSD symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5).

    Measured: Baseline to end-of-treatment visit (Week 17 in the GMAT; Week 13 in the IMAT)

Secondary outcomes (6)

  1. Safety and tolerability

    Severity, incidence and frequency of adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs) and serious adverse events (SAEs).

    Measured: From baseline through end-of-study visit (Week 17 in the GMAT; Week 13 in the IMAT)

  2. Suicidal ideation and behavior assessed with C-SSRS

    Incidence of serious suicidal ideation and positive suicidal behavior assessed with the Columbia Suicide Severity Rating Scale (C-SSRS).

    Measured: From baseline through end-of-study visit Week 17 in the GMAT; Week 13 in the IMAT), assessed throughout the treatment period

  3. Change in systolic and diastolic blood pressure

    Mean change in systolic and diastolic blood pressure from pre-investigational product (IP) administration to the end of each Experimental Session.

    Measured: From pre-IP administration to end of each Experimental Session (Weeks 6, 10, and 14 in the GMAT arm; Weeks 4, 7, and 10 in the IMAT arm)

  4. Change in heart rate

    Mean change in heart rate from pre-investigational product (IP) administration to the end of each Experimental Session.

    Measured: From pre-IP administration to end of each Experimental Session (Weeks 6, 10, and 14 in the GMAT arm; Weeks 4, 7, and 10 in the IMAT arm)

  5. Change in respiratory rate

    Mean change in respiratory rate from pre-investigational product (IP) administration to the end of each Experimental Session.

    Measured: From pre-IP administration to end of each Experimental Session (Weeks 6, 10, and 14 in the GMAT arm; Weeks 4, 7, and 10 in the IMAT arm)

  6. Change in body temperature

    Mean change in body temperature from pre-investigational product (IP) administration to the end of each Experimental Session.

    Measured: From pre-IP administration to end of each Experimental Session (Weeks 6, 10, and 14 in the GMAT arm; Weeks 4, 7, and 10 in the IMAT arm)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study start24 Dec 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized in a 1:3 ratio (individual MDMA-assisted therapy : group-based MDMA-assisted therapy).
Masking
None (open label)
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07469098
Sponsor's protocol ID
SHEBA-0894-23-RA-CTIL
Status last verified
Mar 2026
First submitted
10 Feb 2026
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MDMA HCl in people with PTSD, run by Sheba Medical Center at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Revital Amiaz (972542378757, revital.amiaz@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PTSD symptoms as measured by CAPS-5 (time frame: Baseline to end-of-treatment visit (Week 17 in the GMAT; Week 13 in the IMAT)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07469098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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