Study Initiation Visits Begin for Phase 3 Lead-In Trials of MDMA-Assisted Therapy for PTSD

Throughout September 2017, MAPS and MAPS Public Benefit Corporation (MPBC) clinical staff completed 9 of 14 study initiation visits for sites selected to conduct Phase 3 lead-in trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) across the United States and Canada. These study initiation visits serve to train clinical trial sites in study procedures.

We will conduct an open-label lead-in training study at Phase 3 sites starting this fall, which will enroll 1-4 participants per site over the next 6-8 months. Each co-therapist team will work with a single participant at their respective study site.

The Phase 3 trials starting early next year will assess the efficacy and safety of MDMA-assisted psychotherapy in participants with PTSD, aged 18 and older, at sites in the U.S. and Canada. Participants will be randomized to receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week treatment period, along with 12 associated 90-minute non-drug preparatory and integration sessions. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters. Learn more…