The Food and Drug Administration’s 2016 approval of phase 3 MDMA trials for post-traumatic stress disorder marked a turning point in the drug’s return to medical research. It moved MDMA-assisted therapy toward a decisive test in larger clinical studies, but did not itself establish the treatment’s efficacy or authorize doctors to prescribe MDMA routinely.

The regulatory milestone

The approval, secured in 2016, allowed the Multidisciplinary Association for Psychedelic Studies to proceed to phase 3 trials of MDMA as a treatment for PTSD. By the time the international psychedelic community gathered in Oakland in April 2017, phase 3 trials had also received Food and Drug Administration approval for MDMA, while psilocybin was described as not far behind. The distinction was consequential: permission to test a treatment at this stage represented progress toward possible medical use, not approval of the drug as a prescription treatment. At the conference, the prospect of rescheduling and prescribing remained conditional on the trials’ results.

MAPS and the return to clinical research

The approval belonged to a longer campaign by the Multidisciplinary Association for Psychedelic Studies, the nonprofit Rick Doblin established in 1986 to support research and restore public and scientific respectability to psychedelics. Based in Santa Cruz, California, the organization concentrated much of its effort on MDMA-assisted therapy for people with PTSD. The approval to conduct phase 3 trials gave that work a new institutional standing after decades in which psychedelic research had been pushed to the margins.

The Food and Drug Administration designated MDMA a “breakthrough therapy” in 2017, clearing the way for expedited review. The designation was another regulatory step, not a finding that phase 3 trials had already proved the treatment. Together, the two decisions brought MDMA research closer to the process through which a therapy might eventually become available, while leaving that outcome dependent on further evidence.

A drug recast as a therapeutic adjunct

MDMA had a history that crossed sharply different settings. Merck first synthesized the compound in 1912, but did not market it. After Alexander “Sasha” Shulgin resynthesized it in the 1970s, MDMA became a popular adjunct to psychotherapy; its empathogenic qualities were thought to help patients form bonds of trust with therapists. In the 1980s it also became associated with the rave scene, and in 1986 the United States government placed it in Schedule I, declaring it a drug of abuse with no accepted medical use. The later clinical trials therefore sought to evaluate a therapeutic use for a substance whose public and legal identities had long been shaped by nonmedical use and prohibition.

Public significance and limits

The shift was visible at Psychedelic Science 2017, organized by the Multidisciplinary Association for Psychedelic Studies. A gathering that had been modest in 2010 had grown into a six-day conference drawing more than three thousand people from around the world, with researchers from twenty-five countries presenting findings. During the conference, Rick Doblin told a reporter, “We are not the counterculture. We are the culture.” The remark captured the changed public position of psychedelic research, even as the trials themselves still had to establish whether MDMA-assisted therapy could meet the standards required for medical approval.