Data from a Phase III trial suggests that MDMA could improve mental health when combined with therapy. The study found that MDMA-assisted therapy was more effective than talk therapy in helping patients with post-traumatic stress disorder. The results of this trial and others will likely lead to a formal approval of MDMA by the Food and Drug Administration in the near future.
MDMA, also known as 3,4-methylenedioxy-methamphetamine, is a synthetic drug with both stimulant and psychedelic effects. It can cause a distorted sense of time and space. In the 1980s, it was designated an illegal substance by the U.S. federal government due to its popularity as a club drug. A small group of psychologists used MDMA as a way to boost the effects of therapy.
New research and a successful push for the legalization of drugs in general has renewed attention to MDMA-assisted therapy. In the last few years, the FDA has agreed to consider a formal approval of MDMA for PTSD, pending positive results from randomized, double-blind, placebo-controlled Phase III trials, which are considered the gold standard of clinical research.
The first results from the Phase III trial of 90 patients with severePTSD were published last year. Compared to placebo, MDMA-assisted therapy was highly effective and well-tolerated, even among patients with other relevant health conditions. Two months after the last therapy session, about two-thirds of patients who took MDMA no longer fit the criteria for activePTSD.
At the spring meeting of the American Chemical Society, Mitchell and her team reported follow-up data from the study, which showed that the improvements seem to last longer after the initial treatment.
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