Michael Mithoefer, MD
Multidisciplinary Association for Psychedelic Studies
MDMA-assisted Psychotherapy for PTSD – Update and Observations from Clinical Trials
It is now widely recognized that psychotherapy is the definitive treatment for posttraumatic stress disorder (PTSD), however despite advances in trauma focused therapies, existing treatments have high dropout rates and are ineffective for a large percentage of patients. MDMA-assisted psychotherapy is a novel approach aimed at catalyzing psychotherapy with a pharmacologic agent administered only a few times during eight-hour psychotherapy sessions. Six Phase 2 Clinical Trials studying MDMA as an adjunct to psychotherapy have now been completed in the US , Canada, Switzerland and Israel. The pooled results of the six Phase 2 studies showed a large effect size treating both veterans and civilians with PTSD who had not responded to prior treatments. Based on the promising results of these studies, The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to expedite Phase 3 Studies now underway at 18 sites in the US, Canada and Israel. Similar protocols are under development in Europe, and trials are expected to begin in The Netherlands and The Czech Republic in early 2020, with trials in other European countries expected later in the year. The manualized treatment model developed for this research is an inner-directed approach in which the therapists’ role is to support and facilitate, rather than direct, the patient’s spontaneously unfolding process. This process will be illustrated with participant quotes and a video clip.
Michael Mithoefer, MD is a Clinical Investigator and acting Medical Director of MAPS Public Benefit Corporation. He and his wife, Annie, completed the first phase 2 clinical trial of MDMA-assisted psychotherapy for PTSD in 2009 and a subsequent study of MDMA-assisted psychotherapy for PTSD in military veterans, firefighters and police officers. They are now supervising therapists in the ongoing MAPS Phase 3 trials of MDMA-assisted Psychotheapy for PTSD, leading trainings in MDMA- assisted psychotherapy for therapists interested in working on clinical trials, and providing FDA-approved MDMA sessions for research therapists. He is Clinical Assistant Professor of Psychiatry at the Medical University of South Carolina, is a Grof certified Holotropic Breathwork Practitioner, has been a Certified Internal Family Systems Therapist, and has been board certified in Psychiatry, Emergency Medicine and Internal Medicine.