The Multidisciplinary Association for Psychedelic Studies (MAPS) announced the results of a double-blind, multi-site Phase 3 study of MDMA-assisted therapy for post-traumatic stress disorder (PTSD).
The study had 104 individuals randomized to either a group that received 80 to 120mg of MDMA hydrochloride followed by a supplemental half-dose of 40 or 60mg during three extended sessions of therapy, or a group that received placebo plus extended sessions of therapy.
The study enrolled participants with PTSD for a 12-week treatment period, and participants reflected the U.S. demographics of those living with PTSD, with people of color representing more than half of those enrolled in the study.
Both the primary endpoint and secondary endpoints were met. The primary endpoint was a significant positive change from baseline in Clinician-Administered PTSD Scale for DSM-5, and the secondary endpoint was an improvement in functional impairment associated with PTSD as measured by the change from baseline in the Sheehan Disability Scale.
No serious adverse events were observed in either the MDMA group or the control group.
With two positive Phase 3 trials complete, MAPS is preparing to submit a new drug application for FDA approval by the third quarter of 2023.
Healthesystems has previously reported on this topic, as it may be relevant to worker populations that may develop PTSD, particularly first responders who may encounter traumatic events in the line of duty.