MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder (PTSD) (Proof of Principle Study)
MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD)
Principal Investigator: Michael Mithoefer, M.D., with co-therapist Ann Mithoefer, B.S.N.
Location: Charleston, SC (USA)
MAPS’ "proof of principle" Phase 2 pilot study is the first-ever protocol evaluating MDMA’s therapeutic applications in clinical trials conducted under an FDA IND. Like all of MAPS’ psychedelic-assisted psychotherapy studies, the protocol is randomized, double-blind and placebo-controlled. All twenty-one subjects with treatment-resistant PTSD, as a result of sexual abuse, crime, or war, have completed the experimental treatment. The study was completed in September 2008 with remarkably promising results.
On July 27, 2010, data collection was completed for the long-term follow-up to this study. We collected Clinician-Administered PTSD Scale (CAPS) measurements from 17 of the 20 subjects who received treatment. All 20 subjects filled out a questionnaire developed internally to assess long-term effects. The average length of time between the final experimental treatment session and the follow-up data collection was 3½ years. On November 20, 2012, the paper describing the long-term follow-up results was published in the Journal of Psychopharmacology. The long-term follow-up found that the benefits persisted over time, though a few subjects had relapsed due to new life stressors.