Phase 2 Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD: Database Interim Locked

On December 10, 2019, MAPS Public Benefit Corporation (MAPS PBC) locked the 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. This officially brings the data collection phase of the study to an end. With this final set of data, the research team will analyze the data and 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 are currently developing 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.