A Clinical Plan for MDMA (Ecstasy) in the Treatment of Posttraumatic Stress Disorder (PTSD): Partnering with the FDA

Regulatory agencies in the United States and Spain have determined that the potential benefits of MDMA-assisted psychotherapy for chronic posttraumatic stress disorder (PTSD) outweigh the risks under specific conditions, approving pilot studies for patients who did not improve with at least one prior conventional treatment. These trials, funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), are the only therapeutic MDMA studies worldwide. A rationale explains MAPS's focus on MDMA and PTSD. A Clinical Plan outlines the required safety and efficacy trials, estimated to cost about 5 million dollars and take about five years, developed partly from analyzing Pfizer's Zoloft approval process for PTSD.

Study at a glance

Abstract

The FDA and the Spanish Ministry of Health have concluded that the risk/benefit ratio is favorable under certain circumstances for clinical studies investigating MDMA-assisted psychotherapy. Both agencies have approved pilot studies in chronic posttraumatic stress disorder (PTSD) patients who have failed to obtain relief from at least one course of conventional treatment. These studies, the only ones in the world into the therapeutic use of MDMA, are being funded by a nonprofit research and educational organization, the Multidisciplinary Association for Psychedelic Studies (MAPS, www.maps.org). A rationale is offered explaining why MAPS chose to focus its limited resources on MDMA, and also on PTSD patients. A Clinical Plan is elaborated for the conduct of the "adequate and well-controlled" trials necessary to evaluate the safety and efficacy of MDMA-assisted psychotherapy for PTSD, with the studies estimated to cost about 5 million dollars and to take about five years. The Clinical Plan has been developed, in part, through analysis of the studies conducted by Pfizer in its successful effort to have Zoloft approved by the FDA for use with PTSD patients, and through review of transcripts of the FDA's Psychopharmacologic Drugs Advisory Committee meeting that recommended approval of Zoloft for PTSD.