Ecstasy Is Now Being Taken Seriously By the FDA
The drug just received “breakthrough” status as a treatment for severe PTSD.
by Jesse Hicks
Aug 29 2017, 9:01pm
Paul Faith / Press Association via AP Images
More from tonic
Psychedelic drugs are having something of a renaissance in medicine, particularly in psychology. People with addiction have been tripping on shrooms to get sober, and research has suggested that ketamine might work as an antidepressant and that using psychedelics could help diminish suicide risks.
One of the most compelling avenues of research involves combining psychotherapy with MDMA, better known as ecstasy, to treat post-traumatic stress disorder (PTSD). Researchers at the Multidisciplinary Association for Psychedelic Studies (MAPS)—a nonprofit founded in 1986 to support research and education about psychedelics and marijuana—have spent years trying to get the FDA to recognize MDMA's therapeutic potential.
Their newest work has been so successful that the Food and Drug Administration recently designated MDMA as a breakthrough therapy, recognizing the preliminary evidence that it may be a distinct improvement over current treatments. (The FDA created the breakthrough program in 2012 in order to help speed the development and review of prescription drugs for severe or life-threatening conditions.)
Currently, only two drugs are approved to treat PTSD: Zoloft and Paxil, both selective serotonin reuptake inhibitors (SSRI) taken for depression and anxiety, among other uses. But they've been largely ineffective among soldiers with combat-induced PTSD. "If you're a combat veteran with multiple tours of duty, the chance of a good response to these drugs is 1 in 3, maybe lower," John Krystal, chairman of psychiatry at Yale University and a director at the department of Veterans Affairs National Center for PTSD, told the Washington Post. "That's why there's so much frustration and interest in finding something that works better."
PTSD is particularly insidious because it springs from an original trauma—experiencing or witnessing war, abuse, or violence—that is often so intense that the patient can't confront it. Most traditional psychotherapy involves talking through powerful emotions in order to come to terms with them. PTSD, experts say, thwarts that process. In fact, there's evidence that it permanently changes personalities, making the patient more withdrawn isolated, and distrustful. In veterans, prolonged and repeated exposure to combat can make PTSD even harder to treat.
That's where MDMA comes in. The drug increases empathy and trust in patients who take it, potentially making them more open to psychotherapy. MAPS researchers have tested that hypothesis under close supervision by the FDA. As part of a larger process of psychotherapy treatment, they gave MDMA to study subjects with PTSD at the beginning of multiple, eight-hour therapy sessions. A pair of therapists then led patients through a discussion of their traumatic memories and experiences.
Among 107 patients, 61 percent saw reductions in symptoms. The decrease was so impressive, in fact, that they no longer fit the criteria for PTSD. A year later, follow-up studies showed 67 percent no longer had PTSD. And data showed some patients treated with psychotherapy and MDMA had marked, permanent personality changes—they were more open, less withdrawn. The results are being prepared for publication, but the FDA has seen them.
"If you were to design the perfect drug to treat PTSD, MDMA would be it," MAPS founder Rick Doblin told the Post. The group specifically chose PTSD for study, knowing the idea of testing illegal drugs would raise eyebrows, Doblin said, and PTSD is more prevalent in veterans than in the general population. "We wanted to help a population that would automatically win public sympathy. No one's going to argue against the need to help them."
Maybe so, but one researcher told the Post he worries about the effect legitimizing MDMA might have on the general public interested in recreational use. Andrew Parrott is a psychology professor at Swansea University in Wales and has spent years studying MDMA. "I think it's a dangerous substance," he said, suggesting that FDA approval could lead the public to believe MDMA is completely harmless, even though street ecstasy can contain other substances that users might not realize.
Of course, any drug can have risks, and other researchers sound cautiously optimistic. "I can't think of a single medication that doesn't carry some side effect," Krystal told the Post. "The question here is whether the benefits outweigh the risk."
As MAPS and the FDA move forward, that's one question they'll be looking to answer. In the spring they'll begin their Phase 3 trial—the final phase before regulators decide whether a drug can go to market. Between 200 and 300 adults with severe PTSD will receive 12 weeks of psychotherapy supplemented by three, day-long therapy sessions where they'll be randomly assigned to take either MDMA or placebo. The results will be evaluated by an independent pool using a standard PTSD scale. The FDA has also approved the design of MAPS' phase 3 program and the groups agreed on additional measures to make sure that doctors who evaluate the subjects don't know who received the real drug.
MAPS still needs needs about $12 million of its $25 million budget for the trial. If all goes well, veterans and psychologists who've long struggled with treating PTSD may find themselves with a new tool to reverse it: FDA-approved use of MDMA as treatment for PTSD could be approved as soon as 2021, Doblin said.