As of May 15, 2019, thirteen of fifteen sites are officially screening for our FDA-regulated Phase 3 clinical trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). Newly screening study sites are Madison, Wisconsin, Vancouver, British Columbia, Montreal, Canada, and Be’er Ya’akov, Israel.
Taking place at 15 locations across the United States, Canada, and Israel, study participants will be administered MDMA or placebo in conjunction with psychotherapy at research sites in the following locations:
- Charleston, SC
- Boulder, CO
- Fort Collins, CO
- Los Angeles, CA
- New Orleans, LA
- San Francisco, CA (UCSF and private practice)
- New York, NY (NYU and private practice)
- Boston, MA
- University of Wisconsin-Madison
- Vancouver, British Columbia
- Montreal, Canada
- Be’er Ya’akov, Israel
- Tel HaShomer, Israel (Sheba Medical Center)
Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe 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-assisted psychotherapy as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in a clinical setting.