Spotlight Research Presentations
Trauma and Stressor Related Disorders and Disasters
Kenneth R. Weingardt, Ph.D.
Director, Veterans Research Program
Healing Breakthrough Foundation
Boulder, Colorado
Maciej Gonek, Ph.D.
Program Manager, Veterans Research Program
Healing Breakthrough Foundation
San Rafael, California
MDMA-Assisted Therapy (MDMA-AT) involves the use of prescribed doses of MDMA as an adjunct to psychotherapy sessions. The basic premise is that the therapeutic effect is not due simply to the physiological effects of the medicine; rather, it is the result of an interaction between the effects of the medicine, the therapeutic setting and the mindsets of the participant and the therapists. MDMA-AT has historically used a non-directive approach to help individuals to identify their inner healing wisdom which is thought to guide them as they process the traumatic memories linked to their PTSD (Mithoefer et al, 2017)
Six Phase II randomized trials demonstrated acceptable safety and promising initial efficacy results (Mithoefer, et al, 2019). The FDA granted Breakthrough Therapy Designation to MDMA-AT in 2017 and approved the designs of two Phase III trials that started in 2018. In the first Phase 3 randomized double-blind study (Mitchell et al., 2021), participants underwent three 8-hour experimental sessions spaced four weeks apart in addition to three preparatory and nine integrative therapy sessions. Using the CAPS-5 as a primary outcome, 88% of those who received MDMA-AT experienced clinically significant reduction PTSD symptoms, while only 60% of patients who received the placebo achieved a similar reduction.
These remarkable results may be further enhanced by leveraging manualized, evidence based, trauma focused therapies such as Prolonged Exposure (Foa, et al 2019), or Cognitive Processing Therapy (Resick, et al 2016) in the MDMA-Assisted Therapy framework. This novel approach would marry an empathogen (MDMA) with an existing first line treatment for PTSD. It is consistent with recent arguments that cognitive-behavioral approaches should be the default for Psychedelic Assisted Therapies (Yaden, D.B. et al., 2022) because they avoid issues of cultural insensitivity, make minimal assumptions about the nature of mind and reality, and have the largest evidence base regarding safety and effectiveness outside of psychedelic therapy. The presentation will conclude with a brief case study highlighting some of the challenges and opportunities inherent in this approach.