MDMA Plus Exposure Therapy for PTSD

Exclusion Criteria

• •Are not able to give adequate informed consent.
• •Have previously participated in a Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored MDMA clinical trial.
• •Have any current problem which, in the opinion of the investigator or study physician might interfere with participation.
• •Have hypersensitivity to any ingredient of the Investigational Medicinal Product (IMP).
• •Upon review of medical or psychiatric history and assessment, have any current or past diagnosis that would be considered a risk to participating in the study
• •Current or past substance abuse that would be considered a risk for participating in the study
• •Requires ongoing psychiatric medication use with certain exceptions. Individuals may decide to taper psychiatric medications under the guidance of their local provider.
• •Have a history of any medical condition that could make receiving MDMA dangerous because of increases in blood pressure and heart rate or any medical condition the study physician believes would pose a safety risk or interfere with the effects of the treatment. Any medical disorder judged by the investigator to significantly increase the risk of MDMA administration by any mechanism is exclusionary.
• •Have any unstable medical condition that would interfere with participation.
• •Have uncontrolled hypertension) documented on three separate occasions.
• •Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
• •Have a history of ever having ventricular arrhythmia or any other abnormal heart rhythm that the study physician believes would pose a significant risk of participation.
• •Have an abnormal finding on electrocardiogram
• •Have a history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
• •Require the use of concomitant medications that could impact the effects or safety of MDMA during the Medicine Session.
• •Have symptomatic liver disease or significant liver enzyme elevations.
• •Have a history of hyponatremia or hyperthermia.
• •Weigh less than 48 kilograms (105 lbs.).
• •Are pregnant or nursing
• •Have engaged in ketamine-assisted therapy or used ketamine within 12 weeks of enrollment.