Phase 2 Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD: Data Under Review

On December 10, 2019, MAPS Public Benefit Corporation (MAPS PBC) completed an interim lock of the existing database for our Phase 2 open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at sites across the United States and Canada. A total of 42 people were enrolled in the study, with 37 treated, and a total of 36 participants completed the study. With this preliminary set of data from 36 subjects, the research team will analyze the data for submission to FDA and will write a paper for submission to a peer-reviewed scientific journal. The purpose of this study is to provide the final training and supervision for our co-therapy teams as they work with one study participant with PTSD. The same treatment approach will be used in Phase 3. We have developed a long-term follow-up protocol for this multi-site open-label Phase 2 study, which will assess symptoms of PTSD in participants 12 months after completing treatment.