What I Think: PTSD and Ecstasy: an Unlikely Pair
One of the main targets in the war on drugs could well become a drug to treat the scars of war. The U.S. Food and Drug Administration (FDA) has designated 3,4-methylenedioxymethamphetamine (MDMA), better known as the illegal drug ecstasy, a “breakthrough therapy” for post-traumatic stress disorder (PTSD), a status that may lead to faster approval.
The agency has also approved the design for two phase III studies of MDMA for PTSD that would be funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit in Santa Cruz, California. MAPS announced the “breakthrough therapy” designation, made by FDA on August 16, on its website recently. If the group can find the money for the trials, which together could cost an estimated $25 million, they may start next spring and finish by 2021.
In people with PTSD, a small sensory trigger such as a sound or a smell can bring a traumatic memory rushing back. The disabling element of PTSD is the fact that when the memory starts, the emotions completely override you and overwhelm the brain. Studies suggest that MDMA can dampen the emotional response to the memory, allowing people to relive their trauma and work through it. The MDMA-treatment consists of several sessions of psychotherapy, some conducted while the patient is under the influence of the drug.
A small U.S. study that first suggested MDMA could help treat PTSD was published in 2011. Since then, researchers in Canada, Israel, and the United States have jointly carried out larger phase II trials funded by MAPS; their results, which remain unpublished but have been reviewed by the FDA, were very good. Overall, 107 participants who had suffered from PTSD for an average of 17.8 years were treated in the phase II trials. Of the 90 patients who were available to be studied 12 months later, 61 no longer had PTSD.
In late July, MAPS and the FDA agreed on how the coming phase III trials—usually the last hurdle before seeking a drug’s approval from regulators—should be conducted. In the near future after approval using MDMA and psychotherapy together may become a commonplace treatment for PTSD and hopefully give those suffering hope again.