By Allison Kannam
In August, the Food and Drug Administration (FDA) designated 3,4-methylenedioxymethamphetamine (MDMA), more commonly known as ecstasy, “breakthrough therapy” status for patients with post-traumatic stress disorder (PTSD). The FDA grants this status to interventions that show evidence of offering significant improvements for severe conditions, and helps speed up the process of development and review.
The Multidisciplinary Association for Psychedelic Studies (MAPS) has been the driving force behind research on MDMA for decades. Recently, the FDA approved two MAPS-funded phase III studies on MDMA’s effect on PTSD. If MAPS can raise enough money, these studies would begin in spring 2018 and finish in 2021. In addition to taking ecstasy, patients would attend psychotherapy sessions, some while under the influence of the drug. Individuals experiencing PTSD can become overridden by emotions attached to a memory, and MDMA may help diminish some of this emotional response to allow them to work through their trauma.
Previously, MAPS funded phase II trials with favorable results; 61 of 90 patients in the experimental groups no longer experienced PTSD at 12-month follow up. In previous studies, researchers have grappled with how to minimize bias and avoid a placebo effect, since participants can often tell if they are taking the active drug. When researchers attempted to provide a low-dose of MDMA for the control group, it actually caused more discomfort for patients without any benefit, so they decided to keep the control group on an inactive placebo and implement measures to ensure that doctors do not know which group a patient is in.
While interventions using ecstasy to treat PTSD are certainly innovative, David Null, a neuropsychopharmacologist at Imperial College London, indicates that the potential medicinal aspects of these drugs have been known for decades. Rather than a “big scientific step,” he states, “it’s a huge step in acceptance.”
Kupferschmidt, K. (2017, August 26). All clear for the decisive trial of ecstasy in PTSD patients. Science. doi:10.1126/science.aap7739