MDMA Moves Closer to Approval for PTSD Treatment After New Clinical Trial

If endorsed by the FDA, the drug would become the first psychedelic approved for mental health treatment in the United States

two pills filled with powder
MDMA, also called molly or ecstasy. Andrew Lichtenstein / Corbis via Getty Images

A new clinical trial suggests that the drug MDMA, paired with therapy, is effective in reducing symptoms in patients with post-traumatic stress disorder (PTSD). The study paves the way for the Food and Drug Administration (FDA) to approve MDMA-assisted psychotherapy as the first new treatment for PTSD in two decades.

“These are very encouraging results, which suggest that this approach may benefit PTSD,” Allan Young, who studies mood disorders at King’s College London, tells New Scientist’s Jason Arunn Murugesu. “Although the benefits and harm should be confirmed in further research, this study brings this new treatment much closer to clinical use.”

MDMA—also called ecstasy, molly or 3,4-methylenedioxymethamphetamine—is a well-known party drug commonly used in music festival or rave settings because of its ability to make users feel alert, excited and connected to one another. MDMA works by increasing the activity of at least three neurotransmitters: serotonin, dopamine and norepinephrine. Because the chemical serotonin, which helps with mood regulation, reward and learning, is slowly produced, it can become depleted in the brain after taking MDMA, and some users report feeling anxious, fatigued or depressed for days post-use. 

But before it emerged as a party drug in the 1980s, a small group of psychiatrists used MDMA in clinical settings to help patients communicate and achieve insights about their trauma, writes the New York Times’ Rachel Nuwer. At that time, during the 1970s and 1980s, the drug had not undergone clinical trials. Despite its potential for therapeutic uses, in 1985, the U.S. Drug Enforcement Administration classified MDMA as a Schedule I Drug, meaning it had no currently accepted medical use and a high potential for abuse. Many other countries also criminalized MDMA around this time.

“The big tragedy to point out is that it was pretty clear in the late 1970s and early 1980s that MDMA had incredible therapeutic potential,” Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), which sponsored the study, tells the Times. “All the suffering since then, because MDMA was criminalized, is enormous.”

Earlier this year, Australia became the first country to allow clinicians to prescribe MDMA and psilocybin, the hallucinogenic ingredient in magic mushrooms, for controlled clinical use. If MDMA earns FDA approval for mental health treatment, it will become the first psychedelic drug to earn that designation in the United States.

In the new study, researchers tested MDMA-assisted therapy on more than 100 diverse participants with moderate to severe PTSD. For 18 weeks, 52 patients received treatments consisting of therapy combined with MDMA, while 51 received therapy with a placebo. Neither patients nor their therapists were told who was given MDMA. 

After 18 weeks, 85 percent of patients receiving MDMA had a “clinically meaningful improvement,” compared to 69 percent of the placebo group, per the study. Additionally, 46 percent of participants in the MDMA group met remission criteria, compared to 21 percent of those who received a placebo. The research was published last week in Nature Medicine

“Participants in the study often reported the ability to tap into self-compassion and allow themselves to look at what happened from a different lens,” lead author Jennifer Mitchell, a neurologist at the University of California San Francisco, tells Catherine Ho of the San Francisco Chronicle. “Instead of shutting down from shame, they might instead say, ‘That was a terrible thing that happened to me, but it wasn’t my fault, and it doesn’t define me, and I can move on.’ That seems to be very healing.” 

Following a Phase 3 clinical trial completed in 2021, the new study marks the second and final Phase 3 trial that MAPS needs to apply for FDA approval. The organization plans to submit its application before the end of 2023, meaning the administration could approve the treatment as soon as next year, per the Chronicle

“This is basically the last step prior to asking the FDA for approval, which is an enormous landmark in mental health treatment,” Boris Heifets, an anesthesiologist at Stanford who was not involved in the study, tells the Chronicle. “That opens the door to a new type of therapy.”

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