FDA Approves Large Clinical Trial For Ecstasy As Relief For PTSD Patients



An anonymous reader quotes a report from Ars Technica: The Food and Drug Administration on Tuesday approved the first large-scale, phase 3 clinical trial of ecstasy in patients suffering from post-traumatic stress disorder (PTSD), the New York Times reported. The regulatory green-light follows six smaller-scale trials that showed remarkable success using the drug. In fact, some of the 130 PTSD patients involved in those trials say ecstasy — or 3,4-Methylenedioxymethamphetamine (MDMA) — saved them from the devastating impacts of PTSD after more than a decade of seeing no improvement with the other treatment options available. Currently, the best of those established treatment options can only improve symptoms in 60 to 70 percent of PTSD patients, one expert noted. However, after one of the early MDMA studies, the drug had completely erased all traces of symptoms in two-thirds of PTSD patients. The new Phase 3 trial will involve at least 230 patients and is planned to start in 2017. Like the other trials, it is backed by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit created in 1985 to advocate for the medical benefits and use of psychedelic drugs, such as MDMA and marijuana. Also like the others, the new, larger trial will involve a limited number of MDMA treatments administered by professional psychotherapists as part of a therapy program. In previous trials, patients spent 12 weeks in a psychotherapy program, including three eight-hour sessions in which they took MDMA and talked through traumatic memories.

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