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MDMA was first synthesized in 1912 by Merck. Merck and US Army did several animal trials in the 1950s, but by the end of the decade MDMA was shelved and thought to have no therapeutic benefit. It wasn’t until Sasha Shulgin rediscovered it in 1976 that its therapeutic benefits were discovered, at which point therapists and psychiatrists began quietly using it for psychedelic assisted psychotherapy. In July 1984 the DEA proposed making MDMA a Schedule I controlled substances, which led to outcry from practitioners who requested the DEA hold hearings to provide testimony on MDMA’s therapeutic benefits. While these hearings were ongoing, the DEA used its emergency scheduling authority in May of 1985 to place MDMA in Schedule I.

Animal efficacy and human safety trials of MDMA began in the late 1980s, and the first FDA-approved, placebo controlled, double blind phase I study was published in 1996.