On Tuesday, the Food and Drug Administration authorized a major step toward allowing the medical use of MDMA (also known as ecstasy or Molly) for PTSD patients: The federal agency approved a large-scale, Phase 3 clinical trial of the drug — the last step the drug must overcome before it can become prescription medicine.
If MDMA crosses this final line and gets another FDA approval, it could be legally available by 2021.
“I’m cautious but hopeful,” Charles Marmar, a leading PTSD researcher and head of psychiatry at New York University’s Langone School of Medicine, told the New York Times. “If they can keep getting good results, it will be of great use. PTSD can be very hard to treat. Our best therapies right now don’t help 30 to 40 percent of people. So we need more options.”
But don’t expect MDMA to be legally available at pharmacies anytime soon. The trial, much like other recent research into medical psychedelics, would only enable the use of MDMA in settings supervised by trained health care professionals, and it would be coupled with months, perhaps years, of psychotherapy to help ease PTSD symptoms — which are notoriously difficult to treat, particularly among military veterans.
The trial could unlock MDMA’s use in psychotherapy
The supervised, psychotherapy-focused setting is crucial to MDMA’s success as a medication.
MDMA is a relatively safe drug that poses no serious risk of addiction, but it’s still prone to abuse and may not lead to its desired effects outside the medical setting. Particularly in club and party settings, it can lead to severe body heat and dehydration.
But if it’s used in a medical setting, MDMA’s properties — which can trigger a rush of joy and trust, while at the same time taming fear, anger, and other negative emotions — can be leveraged in a supervised psychotherapy session to help a patient talk about and work through the issues at the core of their psychological trauma and pain. This experience is then followed up on in ensuing psychotherapy sessions to help patients integrate the MDMA experience into their lives.
“The MDMA is used to catalyze the therapeutic process in those eight hours [of the original session] and then it continues to unfold,” Michael Mithoefer, a psychiatrist who’s spearheaded the medical MDMA research, previously told me. “The follow-up is very important.”
Mithoefer explained that MDMA helps patients put traumatizing events — those that lead to PTSD — in a new perspective, one that’s easier to psychologically confront and cope with. “The MDMA allows people to revisit the trauma without being overwhelmed while still having an emotional connection,” he said.
The early research, much of which Mithoefer has conducted along with his wife, shows that MDMA-assisted psychotherapy really can work to reduce PTSD symptoms. But the research done so far has involved small sample sizes — typically a few dozen or so participants — which makes it very difficult to gauge just how applicable the findings are to the broader population of PTSD patients. With a large-scale, Phase 3 clinical trial, we could finally get some more solid conclusions.
There’s been interest in studying MDMA for medical purposes for decades. But following the rise of the club scene in the 1970s and 1980s, the Drug Enforcement Administration cracked down on the drug, banning it for all uses by putting it in the restrictive schedule 1 category in 1985. After that, MDMA research came to a halt.
But in recent years, researchers have taken a new look at MDMA and other psychedelic drugs, pushed by advocacy groups like the Multidisciplinary Association for Psychedelic Studies and Heffter Research Institute. And now that research has advanced enough to put MDMA just one big step away from legitimate medical use.