In November 2022, the U.S. nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) announced that it had completed a second phase-three trial on MDMA as a treatment for PTSD—a step widely seen as the last hurdle to clear before applying for approval from the U.S. Food and Drug Administration (FDA). While the data from that study have yet to be published in a peer-reviewed journal, MAPS says its findings echo the positive results from its first phase-three MDMA trial, published in the journal Nature Medicine in 2021, which found that PTSD patients who took MDMA while also undergoing therapy reported significant improvements in their symptoms 18 weeks after their first dose, compared to those who received a placebo. Rick Doblin, MAPS’ founder and executive director, says his group is preparing to apply for FDA approval based on those data. If all goes well, he says, the drug could be approved as soon as 2024.
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