MDMA for Co-occurring PTSD and OUD After Childbirth (NCT05219175)

Usually NOT eligible if any of the following apply:

• Exclusion Criteria (partial):
• Potential participants are ineligible to enroll in the protocol if they:
• Are not able to give adequate informed consent.
• Prisoners will be excluded
• Are likely, in the investigator's opinion and via observation during the Preparatory Period, to be re-exposed to their index trauma, lack social support, or lack a stable living situation.
• Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation.
• A 12 Lead EKG demonstrates QTc greater than 460 msec at time of screening for any potential participant or for the participants using methadone on an EKG obtained within 72 hours of each MDMA treatment session. An abnormal EKG may be repeated once to confirm the presence of QTc prolongation. 460 msec used as the upper acceptable limit as this study only includes women and the level of QTc that is considered abnormal is 10-20 msec longer for women. Psychiatric History 7\. Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment. 8. Have a history of or a current primary psychotic disorder, bipolar disorder 1 assessed via MINI and clinical interview or dissociative identity disorder assessed via structured clinical interview (SCID). 9\. Have a current eating disorder with active purging assessed via MINI and clinical interview. 10\. Have current major depressive disorder with psychotic features assessed via MINI. 11\. Have a current moderate (not in early remission in the 3 months prior to enrollment based on meeting 4 or 5 of 11 diagnostic criteria per DSM-5) or severe alcohol or cannabis use disorder within the 6 months prior to enrollment (meets at least 6 of 11 diagnostic criteria per DSM-5). 12\. Have an active illicit (other than cannabis or opioids) or prescription drug substance use disorder at any severity within 3 months prior to enrollment. 13\. If there has been a diagnosis of moderate or severe cannabis use disorder within the last six months prior to enrollment, then the participant will need to have tapered off cannabis prior to the time of enrollment in the study and have either entered abstinence, limited cannabis use, or mild cannabis disorder. Mild cannabis use disorder or cannabis use alone are not exclusion criteria, however there can be no use in the 24 hours prior to the medication session. 14\. Have current Personality Disorders Cluster A (paranoid, schizoid, schizotypal),) assessed via SCID-5-PD 15. Investigators will exclude potential participants with high risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, or lack of meaningful social support) 16. 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. Medical History 17\. Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. 19\. 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). 20\. Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease. 21\. Have a history of arrhythmia, other than occasional premature atrial contractions (PACs) or PVCs in the absence of ischemic heart disease, within 12 months of screening. 23\. Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). 24\. Require use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions. Refer to Protocol Section \_12\_\_\_: Concomitant Medications. 25\. Have symptomatic liver disease or have significant liver enzyme elevations. 26. Have history of hyponatremia or hyperthermia. 27. Weigh less than 48 kilograms (kg). 29. Are pregnant or are able to become pregnant and are not practicing an effective means of birth control.