Phase 3 Trials: Study Initiation Visits for 5 Sites Completed

MAPS-sponsored researchers have completed study initiation visits for FDA-regulated Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at five 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

These Phase 3 trials are taking place at up to 16 sites in the U.S., Canada, and Israel.

Clinical trials are starting in September 2018, and 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…