MAPS-sponsored researchers have completed study initiation visits for FDA-regulated Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at 8 United States locations:
- New Orleans, Louisiana
- Fort Collins, Colorado
- Boulder, Colorado
- Private Practice, San Francisco, California
- University of California, San Francisco, California
- Los Angeles, California
- Charleston, South Carolina
- New York, New York
Twenty-one participants have completed treatment in our Phase 2 open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at planned Phase 3 sites across the United States and Canada. Seven study sites are now enrolling and 7 sites are fully enrolled. The study is expected to be completed in early 2019. The purpose of this study is to provide the final training and provide supervision for our co-therapy teams.
Phase 3 clinical trials starting Fall 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.
The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting. Learn more…