Groundbreaking PTSD Trial Moves MDMA Closer to Medical Approval

    On May 3, MDMA—the psychedelic drug colloquially known as Molly or ecstasy—moved one step closer to receiving medical approval for treating post traumatic stress disorder (PTSD).

    Under special guidance from the Food and Drug Administration (FDA), the groundbreaking development comes courtesy of researchers at the Multidisciplinary Association for Psychedelic Studies (MAPS), who enrolled 90 patients suffering from severe, chronic PTSD into a randomized, blinded trial. Forty-six of the participants received MDMA and 44 got a placebo—and they all participated in three sessions of identical talk therapy. Participants included not only combat veterans and first responders, but survivors of everything from sexual assault to mass shootings.

    After 18 weeks, the assessors conducted clinical interviews, evaluating how the participants’ functional impairments improved socially, at home, and in work or at school.

    Sixty-seven percent of the participants in the MDMA group no longer qualified for a PTSD diagnosis, and 88 percent experienced a clinically significant reduction in their symptoms; in the placebo group, 32 percent no longer qualified for a PTSD diagnosis, with 60 percent experiencing a clinically significant reduction in their symptoms.

    “As a result of this study and through the persistent and consistent application of scientific rigor, we have demonstrated that MDMA-assisted therapy is likely to provide relief for people diagnosed with PTSD,” Rick Doblin, the executive director of MAPS, said in a press statement. “Far from having no medical benefit MDMA, when combined with talk-therapy in this protocol, has the potential to catalyze the therapeutic process and generate positive mental health outcomes.”

    The potential benefits of MDMA have long been difficult for scientists to study, after federal officials banned the substance in 1985 and categorized it as a Schedule I drug under the Controlled Substances Act.

    “It’s really good to have another tool in the toolbox for therapists to use,” Carl Hart, a professor of psychology at Columbia University and the author of Drug Use for Grown-Ups, told Filter. “And it’s really good to get the country to start thinking about drugs like MDMA in a more nuanced way. And it’s really good to get the media to start thinking about these drugs in a more nuanced way, too.”

    “Twenty years ago or so, publications were writing that MDMA was neurotoxic—that it causes brain cells to die,” he continued. “Now we are past that point. People can hear you now. Before they couldn’t hear anything other than that it was toxic.” 

    The tide has slowly been shifting. In 2017, the FDA granted a breakthrough therapy designation for MDMA to treat PTSD, which meant that the development and review of the drug could be expedited under guidance from the agency. A second Phase 3 clinical trial is now enrolling participants, as the FDA has granted permission for 50 patients to receive MDMA-assisted therapy before official approval. MAPS hopes that arrives in 2023.

    “MAPS has been drawing the blueprint for therapeutic, regulatory, and cultural advances in psychedelics for 35 years,” Betty Aldworth, the director of communications for MAPS, told Filter. “Our study proves that rigorous researchers can demonstrate safety and efficacy to satisfy the requirements of drug development, and we hope that others will use our blueprints well: with bold vision, diligence toward scientific process, and a commitment to healing over profit.”

    Psychedelics in general have recently burst into the mainstream consciousness. In May 2019, Denver became the first city in the United States to decriminalize psilocybin, the psychoactive compound in magic mushrooms, at the ballot box; that September, Johns Hopkins University unveiled its Center for Psychedelic and Consciousness Research, an academic facility dedicated to studying the medicinal benefits of a range of psychedelics.

    In the years since, many other states have also followed Denver’s example, including Oakland and Santa Cruz in California as well as Somerville, Cambridge, and Northampton in Massachusetts. And more and more localities and states are considering similar initiatives. In November, when Oregon decriminalized small-scale drug possession, the state also began a two-year process to implement legal psilocybin therapy that would treat a bevy of conditions, including anxiety, depression, PTSD and substance use disorder.

     


     

    Photograph by the US Army via Flickr/Creative Commons 2.0 

    • Alex Norcia

      Alex is a staff writer at Filter. He previously worked as a reporter and copy editor at VICE, and has been published in The New York Times MagazineThe Columbia Journalism ReviewThe Nation and The Daily Beast, among other outlets. He is also a freelance editorial consultant for the Foundation for a Smoke-Free World; The Influence Foundation, which operates Filter, has received both restricted and general support grants from the Foundation for a Smoke-Free World. Alex is currently based in Phoenix, Arizona.

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