On October 4, 2017, Health Canada, the Canadian federal institution that regulates drug and health products, sent a No Objection Letter on the protocol and design for the MAPS-sponsored Phase 2 Training Study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), conducted at planned Phase 3 study sites in Vancouver and Montreal.
MAPS Public Benefit Corporation (MPBC) clinical research staff have now completed 10 of 14 Study Initiation Visits for an 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. These Study Initiation Visits provide training on study procedures to clinical trial sites that will receive clinical supervision of MDMA-assisted psychotherapy in preparation for Phase 3.
We will conduct the 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-therapy 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 adult participants with PTSD at sites in the U.S., Canada, and Israel. Participants will be randomized to receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy under direct observation 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.
Enrollment is expected to start in the spring of 2018 in the following locations:
- Los Angeles, CA | private practice
- San Francisco, CA | research institution
- San Francisco, CA | private practice
- Boulder, CO | private practice
- Fort Collins, CO | private practice
- New Orleans, LA | private practice
- New York, NY | research institution
- New York, NY | private practice
- Charleston, SC | private practice
- Madison, WI | research institution
- Boston, MA | research institution
- Montreal, Canada | private practice
- Vancouver, Canada | research institution
- Israel | research institution
The trials build on the promising results of MAPS’ completed Phase 2 clinical trials, and are the final phase of research required by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD, required to be used in conjunction with psychotherapy in an outpatient setting with a residential stay.
MAPS and MPBC staff are excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted psychotherapy. Donations are currently being sought to reach MAPS’ goal of raising $25 million to successfully execute the Phase 3 studies required to gain approval from the FDA for MDMA-assisted psychotherapy by 2021, with approval from the European Medicines Agency (EMA) possibly requiring additional funds. With $15.5 million in hand or in multi-year pledges, there’s still a funding gap we need to close. Learn more…