On February 5, 2019, a MAPS-sponsored Phase 3 study site for MDMA-assisted psychotherapy for PTSD was initiated in Be’er Ya’akov, Israel. Led by Principal Investigator Jana Yakirevitch, M.D., this study will involve participants with PTSD. Phase 3 trials are beginning in mid-March 2019.
Our FDA-regulated Phase 3 multi-site clinical trials of MDMA-assisted psychotherapy for PTSD are continuing to open sites for screening. Taking place at 15 locations across the United States, Canada, and Israel, study volunteers 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 as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in a clinical setting.