MDMA Plus Exposure Therapy for PTSD

Exposure-based interventions for PTSD have strong empirical support and involve helping PTSD patients confront feared trauma-related memories and triggers in a therapeutic manner so that distress decreases. This study will involve massed exposure therapy, which involves daily therapy sessions for two weeks, in combination with a one-time administration of MDMA. This is an open-label trial in which all enrolled participants will receive MDMA administration during treatment. An initial phone screen will be conducted for interested individuals to describe the study and assess eligibility. Following the phone screen, informed consent will occur. Interested individuals will also complete a drug test in their local community to be reviewed by the study team. For individuals interested in tapering their psychiatric medication, this may be done with a local provider or study physician. In this event, a psychiatric assessment will be conducted at the end of medication tapering to reassess eligibility. For those who choose to participate and are eligible, the first day will include a medical and psychiatric assessment to confirm eligibility, a blood draw to check medical labs, a psychophysiological assessment, completion of self-report measures, and one therapy session. Additionally, an optional functional magnetic resonance imaging (fMRI) scan will be offered at the pre-treatment and end-of-treatment visits. Upon confirmation of eligibility, the second day (or Medicine session) will involve MDMA administration followed by two therapy sessions with a break in between. A psychophysiological session will also occur on Day 2. Days 3-10 (which do not involve drug administration) will include a daily exposure therapy session. Psychophysiology will be collected during the therapy session. A psychophysiology session will occur on Days 4, 9, and 10 in addition to Days 1 and 2. Participants will be contacted at one week, two weeks, four weeks, and 6 months after treatment ends to complete symptom assessments via phone or online measures.