F.D.A. Approves Trials of Ecstasy to Treat PTSD Patients
The FDA has granted approval for continuing trials using MDMA to treat post-traumatic stress disorder.
On Tuesday, the Food and Drug Administration gave permission for large-scale, clinical trials of MDMA, the designer drug popularly known as Ecstasy, primarily as treatment for individuals suffering from post-traumatic stress disorder, many of whom are veterans.
“I’m cautious but hopeful,” said Dr. Charles R. Marmar, the head of psychiatry at New York University’s Langone School of Medicine, a leading PTSD researcher who was not involved in the study, 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.”
However, Marmar cautioned that MDMA, as a “feel-good drug,” is prone to abuse, and noted that “prolonged use can lead to serious damage to the brain.”
Six Phase 2 studies and the upcoming Phase 3 research — slated to include at least 230 patients — were funded by the nonprofit Multidisciplinary Association for Psychedelic Studies, which was founded in 1985 to campaign for the legal use of MDMA, LSD, marijuana and other scheduled drugs.
The proposal for approval is contingent on the idea of MDMA being prescribed a limited number of times as part of sessions with a trained psychotherapist, though opponents claim it could encourage individuals to seek out the drug on their own.
MDMA floods the brain with hormones and neurotransmitters that create feelings of bliss and affection. Patients who have been successfully treated with the drug say it allows them to process their trauma from a distance and then talk through in a traditional manner. The drug saw limited use in psychological circles in the 1970s, though it was made a Schedule 1 drug in 1985 after its recreational use spread.
One study tracing the drug’s effects as a form of PTSD therapy — three doses administered under a psychiatrist’s guidance — found that patients reported an average of an over-50 percent decrease in the severity of their symptoms. At the study’s conclusion, two-thirds were no longer considered to be suffering from PTSD.
Additionally, two new studies recently showed that doses of psilocybin — the hallucinogenic compound found in particular species of mushrooms — reduced depression and anxiety in patients with terminal or advanced cancer. Like LSD — which actor Cary Grant was vocal about the positive effects of in therapy — psilocybin was initially used for psychological treatment before being scheduled.