MDMA-Assisted CBCT for PTSD vs CBCT RCT

Exclusion Criteria

• •Participant with PTSD
• •1. Are pregnant or could become pregnant and not using birth control
• •2. Have a history of, or a current psychotic disorder or bipolar 1 disorder or dissociative identity disorder
• •3. Have a history of a medical condition that could make receiving MDMA unsafe (e.g. glaucoma, heart attack, stroke, aneurysm)
• •4. Have a history of Diabetes Mellitus (Type 2) that a doctor determines is not stable
• •5. Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement
• •6. Have high blood pressure, a history of heart disease, heart failure, irregular activity in the heart or require heart medication
• •7. Have liver disease with symptoms
• •8. Have history of hyponatremia (when you have decreased levels of sodium in the blood, which can cause confusion, seizures, fatigue and low levels of consciousness)
• •9. Have history of hyperthermia (when you have a dangerously overheated body, usually in response to hot, humid weather)
• •10. Weigh less than 48 kg
• •11. Have recently engaged in suicidal behaviour or had serious suicidal thoughts (this will be assessed by the study team)
• •12. Require ongoing therapy with a psychiatric medication
• •13. Have a current eating disorder with active purging
• •14. Have current major depressive disorder with psychotic features
• •15. Are a serious risk to others
• •16. Have recently received Electroconvulsive Therapy (ECT)
• •17. Have recently engaged in ketamine-assisted therapy or used ketamine
• •18. Have current substance use disorder with physiological dependence (not including caffeine or nicotine)
• •19. Have recently used "Ecstasy" (material represented as containing MDMA)
• •20. Are not able to give adequate informed consent
• •21. Are not able to adhere to the requirements for procedures, attendance and timing of visits, and observe limits regarding study staff time and support as indicated by a time-limited clinical trial
• •22. Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders
• •Close Significant Other
• •1. Meet criteria for PTSD
• •2. Are pregnant or could become pregnant and not using birth control
• •3. Have a history of, or a current psychotic disorder or bipolar 1 disorder or dissociative identity disorder
• •4. Have a history of a medical condition that could make receiving MDMA unsafe (e.g. glaucoma, heart attack, stroke, aneurysm)
• •5. Have a history of Diabetes Mellitus (Type 2) that a doctor determines is not stable
• •6. Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement
• •7. Have high blood pressure, a history of heart disease, heart failure, irregular activity in the heart or require heart medication
• •8. Have liver disease with symptoms
• •9. Have history of hyponatremia (when you have decreased levels of sodium in the blood, which can cause confusion, seizures, fatigue and low levels of consciousness)
• •10. Have history of hyperthermia (when you have a dangerously overheated body, usually in response to hot, humid weather)
• •11. Weigh less than 48 kg
• •12. Have recently engaged in suicidal behaviour or had serious suicidal thoughts (this will be assessed by the study team)
• •13. Require ongoing therapy with a psychiatric medication
• •14. Have a current eating disorder with active purging
• •15. Have current major depressive disorder with psychotic features
• •16. Are a serious risk to others
• •17. Have recently received Electroconvulsive Therapy (ECT)
• •18. Have recently engaged in ketamine-assisted therapy or used ketamine
• •19. Have current substance use disorder with physiological dependence (not including caffeine or nicotine)
• •20. Have recently used "Ecstasy" (material represented as containing MDMA)
• •21. Are not able to give adequate informed consent
• •22. Are not able to adhere to the requirements for procedures, attendance and timing of visits, and observe limits regarding study staff time and support as indicated by a time-limited clinical trial
• •23. Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders