Stopped: Under review with FDA
The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms.
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Changes in heart rhythm via Carnation Ambulatory Heart Monitor
Timeframe: Throughout the 24 hours prior to each experimental medication session, throughout the duration of each drug administration session, and the 24 hours following each experimental medication session. Up to 64 hours.
Changes in blood pressure
Timeframe: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total.
Change in pulse
Timeframe: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total.
Change in body temperature
Timeframe: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total
Mean change in score of visual analog scale to assess potential for misuse of MDMA
Timeframe: Weekly throughout treatment and at 3-month and 6-month follow-ups. Through study completion, an average of 9 months