A series of Phase 2 and Phase 3 clinical trials of MDMA-assisted psychotherapy for people with Posttraumatic Stress Disorder (PTSD) conducted in North America, Europe and Israel over the past 20 years have demonstrated significant reductions in PTSD symptoms as measured by The Clinician Administered PTSD Scale (CAPS). Based on the results of two recent successful Phase 3 Clinical Trials, MAPS Public Benefit Corporation is preparing to submit an FDA New Drug Application this year for MDMA-assisted psychotherapy for PTSD.
In these studies MDMA was administered three times at monthly intervals during 8-hour MDMA-assisted therapy sessions preceded by careful preparation and followed by integration sessions with two therapists. During the course of this treatment, the psychological process reported by participants varied widely and was often strikingly intense and rich. In this talk, examples will be presented illustrating the range and depth of experiences observed in the trials and will be followed by discussion of potential lessons regarding the nature of psychological healing that appear to go beyond such benefits as fear extinction or corrective attachment.
These observations present exciting and challenging questions that go well beyond our current understanding of neurophysiological mechanisms, and that remind us to avoid reductionist explanations as we are called to further exploration.
Michael Mithoefer, MD, is a psychiatrist living in Asheville, NC. He and his wife, Annie, completed the first MAPS-sponsored Phase Il clinical trial testing MDMA-assisted psychotherapy for crime-related PTSD, and subsequent studies with military veterans, firefighters and police officers, and a pilot study treating couples. He has been Medical Monitor for a series of Phase 2 trials which produced data that led to FDA breakthrough therapy designation. Since 2012 he and Annie have conducted training for research therapists, and supervision of therapists in two recent, successful Phase 3 clinical trials. He completed residency training in Internal Medicine at the University of Virginia and in Psychiatry at The Medical University of South Carolina (MUSC). He has been trained and certified in Grof Holotropic Breathwork, Internal Family Systems Therapy and EMDR. He has been board certified in Psychiatry, Emergency Medicine and Internal Medicine, and is a Fellow of the American Psychiatric Association, Affiliate Assistant Professor at MUSC and Clinical Assistant Professor at Columbia University.