MDMA Plus Exposure Therapy for PTSD

Inclusion Criteria:

• Meet criteria for PTSD

• Willingness of the participant to sign a release for the investigators tocommunicate with their primary care or mental health providers if indicated

• Are able to visually read and understand the English language and give writteninformed consent.

• Are able to swallow pills.

• Agree to have study visits and treatment sessions video and/or audio recorded,

• Must provide a contact (relative, spouse, close friend, or another support person)who is willing and able to be reached by the investigators.

• Must agree to inform the investigators within 48 hours of any medical conditions andprocedures.

• If able to become pregnant, must have a negative pregnancy test prior to studyentry, at study entry, and prior to the Medicine Session. Must agree to use adequatebirth control for a month prior to the Medicine session and through 10 days afterthe Medicine session.

• Agree to the following lifestyle modifications: comply with requirements for fastingand refraining from certain medications prior to Medicine Session, and notparticipate in any other interventional clinical trials during the duration of thestudy and are driven home or to a hotel after the Medicine Session, and commit tomedication dosing, therapy, and study procedures.

Exclusion Criteria:

• Are not able to give adequate informed consent.

• Have previously participated in a Multidisciplinary Association for PsychedelicStudies (MAPS) sponsored MDMA clinical trial.

• Have any current problem which, in the opinion of the investigator or studyphysician 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 orpast 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 inthe study

• Requires ongoing psychiatric medication use with certain exceptions. Individuals maydecide to taper psychiatric medications under the guidance of their local provider.

• Have a history of any medical condition that could make receiving MDMA dangerousbecause of increases in blood pressure and heart rate or any medical condition thestudy physician believes would pose a safety risk or interfere with the effects ofthe treatment. Any medical disorder judged by the investigator to significantlyincrease 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 beensuccessfully eliminated by ablation.

• Have a history of ever having ventricular arrhythmia or any other abnormal heartrhythm that the study physician believes would pose a significant risk ofparticipation.

• Have an abnormal finding on electrocardiogram

• Have a history of additional risk factors for Torsade de Pointes (e.g., heartfailure, hypokalemia, family history of Long QT Syndrome).

• Require the use of concomitant medications that could impact the effects or safetyof 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 ofenrollment.