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

Inclusion Criteria: 1. Are at least 18 years old. 2. At Screening, meet DSM-5 criteria for current PTSD that has been diagnosed past 7/10/23 and the events following. 3. 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. 4. Are fluent in speaking and reading the predominantly used or recognized language of the study site (Hebrew). 5. Are able to swallow pills. 6. 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. 7. 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. 8. Must agree to inform the investigators within 48 hours of any medical conditions and procedures. 9. 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. 10. 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). 11. Holds a permanent address in the next 6 months. Medical History 1. 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. 2. May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed. 3. 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. 4. 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. 5. May have hypothyroidism if taking adequate and stable thyroid replacement medication. 6. May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist. Exclusion Criteria: 1. Are not able to give adequate informed consent. 2. 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. 3. Active military duty expected in the following 12 months. 4. Death of a close person in the past 6 months. Psychiatric History 1. Have received Electroconvulsive Therapy, Transcranial Magnetic Stimulation, or Ketamine Therapy within 12 weeks of enrollment. 2. 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). 3. 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. 4. Have an active illicit (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment. 5. 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. 6. 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: …

Reproduced word-for-word from the public registry record — the study team can answer questions about it.