The Food and Drug Administration (FDA) has approved the design of two Phase 3 clinical trials of MDMA for treating PTSD, according to the Multidisciplinary Association for Psychedelic Studies (MAPS), which is funding and leading the clinical trials.
The MDMA program was created by a small group of psychedelic researchers associated with MAPS who have worked for years to get to this point.
And now, the results have been so positive that the FDA is calling it “breakthrough therapy,” which will put it on a fast track for review and potential approval.
MAPS executive director Rick Doblin set up the group in 1986, one year after the DEA declared MDMA an illegal drug, because he was convinced of its therapeutic potential.
Since then, MAPS has poured millions into MDMA trials for PTSD and other conditions, and has taken the lead in conducting them.
The FDA designation is a “kind of a public acknowledgement of the promise of this research,” Doblin said on the MAPS webpage.
A growing body of research suggests that MDMA and other psychedelic drugs can be effective treatment for ailments ranging from post-traumatic stress disorder to social anxiety in autistic adults.
A small U.S. study that first suggested MDMA could help treat PTSD was published in 2011. Since then, researchers in Canada, Israel and the United States have jointly carried out larger Phase II trials.
Their results, which remain unpublished but have been reviewed by the FDA, were very good, said Doblin.
What we do know is that 107 participants who had suffered from PTSD for an average of 17.8 years were treated in the Phase II trials. Of the 90 patients who were available to be studied 12 months later, 61 no longer had PTSD.
However, because of the stigma attached to psychedelics, many military and government leaders are still hesitant to embrace them.
But, the scope and severity of PTSD among our veterans makes it all irrelevant, according to retired Brig. Gen. Loree Sutton, who until 2010 was the highest-ranking psychiatrist in the U.S. Army.
She now works as New York City’s commissioner of veteran services, per the Washington Post.
“If this is something that could really save lives, we need to run and not walk toward it,” Sutton said. “We need to follow the data.”
PTSD has been a problem for the military for decades, but America’s recent wars have pushed it to epidemic-levels. PTSD-related suicides among veterans are as high as 22 per day, according to data from the Department of Veterans Affairs.
MAPS predicts the trials could be finished by 2021.