Follow-up data from a Phase III trial is the latest to suggest that MDMA—also known as ecstasy—could improve mental health when combined with therapy. The study found that MDMA-assisted therapy was better than talk therapy alone in relieving the symptoms of patients with post-traumatic stress disorder, and that this relief remained durable months later. The results from this trial and others will likely pave the way to a formal approval of MDMA by the Food and Drug Administration in the near future.
MDMA, formally called 3,4-methylenedioxy-methamphetamine, is a synthetic drug with both stimulant and psychedelic effects. It can produce feelings of increased elation, empathy, and a distorted sense of time and space. These properties made it a popular club drug, which led to its designation as an illegal substance by the U.S. federal government in the 1980s. But even before then, a small group of psychologists had experimented with using MDMA as a way to boost the effects of talk therapy sessions.
MDMA-assisted therapy has received renewed attention from the scientific world as of late, buoyed by new research and a successful push for the legalization of drugs in general. And 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.
Last year, a team led by University of California, San Francisco researcher Jennifer Mitchell published the first results from their Phase III trial of 90 patients with severe PTSD. Compared to placebo, MDMA-assisted therapy was highly effective and well tolerated, they found, even among patients with other relevant health conditions, such as depression and a history of substance use disorder. Specifically, two months after the last therapy session, about two-thirds of patients who took MDMA no longer fit the criteria for active PTSD.
On Tuesday, at the spring meeting of the American Chemical Society, Mitchell and her team reported follow-up data from the study, which showed that these improvements seem to last longer still after the initial treatment.
“MDMA is really interesting because it’s an empathogen,” said Mitchell in a statement provided by the American Chemical Society. “It causes the release of oxytocin in the brain, which creates feelings of trust and closeness that can really help in a therapeutic setting.”
Typically, the FDA requires positive data from at least two Phase III trials to consider approving a new drug. Mitchell and her team are already starting to enroll patients for the second trial, and they plan to continue tracking the long-term outcomes of patients from the first trial. Both are being funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit organization that has been shepherding clinical research on psychedelic medicine since its founding in the 1980s. MAPS is also behind the application for the FDA approval of MDMA-assisted therapy, after having obtained an emergency use authorization for its use in 2017.
While legally administered psychedelic medicine is on the rise, there have been challenges and concerns about its use, at least in some contexts. Some advocates have opted to not necessarily wait for FDA approval of treatments like psilocybin-assisted therapy and have instead taken the approach of fighting for the local legalization of these drugs in cities and states, with increasing success. Some researchers have expressed worry about these therapies becoming used by practitioners in these areas without sufficient safeguards, while others have argued that the claimed benefits of these drugs could be inflated.
Should the data from these trials continue to bear out, though, the odds are good that MDMA-assisted therapy for PTSD could be FDA-approved as early as late next year.