On May 24, 2018, Clinical Research Associate, Gabrielle Fortier, M.P.H., of the MAPS Public Benefit Corporation (MPBC), conducted a Study Initiation Visit for a Phase 3 study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at the planned Phase 3 site in Fort Collins, Colorado. A Study Initiation Visit for the Boulder, Colorado study site will be scheduled for June 13, 2018.
The Phase 3 trials starting in the summer of 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at sites in the U.S., Canada, and Israel. Over a 12-week treatment period, participants will be randomized to receive 12 associated 90-minute non-drug preparatory and integration sessions along with three day-long sessions of either MDMA or placebo in conjunction with psychotherapy about a month apart. 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 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.