During the trial, none of the patients had any drug-related side effects or neurocognitive problems related to the drug, the researchers reported.
The study is the first completed randomized, double-blinded clinical trial to evaluate MDMA as an adjunct to psychotherapy in any patient population, the researchers said. It was sponsored by the Multidisciplinary Association for Psychedelic Studies, a Belmont, Mass.-based nonprofit group that focuses on the medicinal uses of psychedelic drugs.
The phase 2 study, the second of three phases of research required by the federal government before approving a drug for a specific use, was published online July 19 in the Journal of Psychopharmacology.
Before MDMA began to be used recreationally under the street name Ecstasy, many psychiatrists and other therapists in the United States and Europe used the compound as a catalyst to psychotherapy, the study authors noted. However, the drug has been illegal in the United Kingdom since 1977 and was criminalized in the United States in 1985.
People with post-traumatic stress disorder who may want to experiment with the drug should know it can be dangerous when not used properly, Mithoefer said. "It needs to be taken in a therapeutic setting with careful monitoring and a lot of follow-up to help patients integrate the experience successfully," he said. "I've had patients with PTSD outside the study tell me that they've used MDMA at a party and had bad experiences, because when feelings about the trauma came up, they weren't prepared to deal with them."
One important limitation of the study, Mithoefer said, was that most participants guessed accurately whether they were in the treatment or the placebo group, and trial investigators could dete
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