Sufferers of post-traumatic stress disorder (PTSD) may soon find relief as the Food and Drug Administration (FDA) has nominated the psychoactive ingredient in the euphoric drug ecstasy as a “breakthrough” therapy to the treat the condition suffered by combat veterans.
The Multidisciplinary Association for Psychedelic Studies (MAPS) announced on Saturday the FDA had “fast-tracked” approval of 3,4-methylenedioxymethamphetamine (MDMA) for further clinical studies.
MDMA is currently illegal, but the FDA’s designation for further clinical trials likely means the drug could mean ecstasy will be made available in prescription form for sufferers of PTSD.
Specifically, MDMA works by increasing the level of certain chemicals in the brain, including serotonin and dopamine, thus allowing those with PTSD to more easily remember traumatic events and express them to a therapist who in-turn may be able to help them overcome their fears.
According to experts’ estimates, anywhere between 11–20 percent of Iraq and Afghanistan veterans have PTSD symptoms. Currently, the only drugs approved by the FDA for PTSD are the anti-depressants Paxil and Zoloft.
“For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way,” said MAPS founder and executive director, Rick Doblin.
MAPS funded research, thanks largely to Silicon Valley donors, has presented its preliminary findings to the FDA.
Although U.S. foreign war veterans have testified about the benefits of MDMA, some in the medical field warn of the its dangers, while others see it as a possible wonder-drug.
“MAPS still isn’t seen as mainstream. But it’s possible they have a point here,” said Dr. John Krystal, head of Yale School of Medicine’s psychiatry department. “I can’t think of a single medication that doesn’t carry some side effect. The question here is whether the benefits outweigh the risk.”
According to MAPS, over 100 subjects who underwent Phase 2 treatment. In a two-month period, over 60 percent of those involved in trials no longer reported the effects of PTSD.
Over a one-year period, an astounding 68 percent no longer reported suffering the effects of PTSD. MAPS’ ambitious goal is to determine how long the drug can effectively treat those suffering from PTSD.
Under MAPS’ plan, between 200–300 volunteers struggling with PTSD will undergo Phase 3 clinical trials. Volunteers will begin clinical tests in 2018 with the expectation trials will conclude in 2021.
Initial trials are set to begin in the U.S., Canada and Israel.
[Army Times] [Popular Science] [The Independent] [Photo courtesy Prezi]