An open label study to investigate the safety and feasibility of delivering 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy to patients with posttraumatic stress disorder

Emyria Ltd0 个研究点目标入组 5 人开始时间: 2023年8月4日最近更新: 2023年8月21日

适应症

试验速览

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•Can provide a support person (relative, spouse, close friend, or other support person) who is willing and able to stay overnight with the participant following each Treatment Session, and who can be reached by the investigators in the event of a participant becoming suicidal or unreachable.
•- If of childbearing potential, has a negative pregnancy test at study entry and prior to each Treatment Session, and agrees to use adequate birth control through 10 days after the last Treatment Session
•- At Screening, has PTSD as diagnosed by a psychiatrist, with a symptom duration of 12 months or longer.
•- At Screening, is an active patient at the study site.
•- Has tried at least two conventional treatments (e.g. two forms of psychotherapy, two medications or a combination of the two) under the supervision of a healthcare professional.

•- Has borderline personality disorder with a history of associated psychotic decompensations.
•- Has evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA.
•- Has a history of or current Diabetes Mellitus (Type 1 or 2), hypothyroidism or glaucoma unless approval for study participation is received from the patient’s treating specialist.
•- Has active alcohol or substance use disorder.
•- Presents current suicide risk (i.e. current plan and intent).
•- Has symptomatic liver disease or has significant liver enzyme elevation.

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