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 19, 2010, the results of this study were published in the Journal of Psychopharmacology. Our paper was the journal's most downloaded article in 2010.

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 three and a half years. Preliminary analysis of the results suggests the benefits of the treatment were maintained. The data is currently being analyzed and Dr. Mithoefer and colleagues will write a new paper for submission to a scientific journal in January 2012.

• Dr. Mithoefer's MAPS-sponsored MDMA/PTSD protocol

• The study has cost $1.2 Million; all of which has been raised.