FDA gives expanded access to MDMA as a treatment for PTSD
Clinics in 10 U.S. cities — including one in Western North Carolina — have been approved by the FDA to expand patient access to MDMA. The recreational drug also known as Ecstasy, will be a treatment for post-traumatic stress disorder.
The program is currently in phase three trials, but the safety and efficacy demonstrated thus far will allow for compassionate use, with an eye on possible FDA approval next year.
Post-traumatic stress disorder has been around as long as trauma has, but it’s only recently been recognized as a formal diagnosis, especially for members of the armed forces exposed to intense or prolonged violence.
Left untreated, PTSD can lead to self-harm, and is considered a major contributing factor to the epidemic of veteran suicides.
“What we've done for years in treatment is try to give people drugs that have tr ied to basically throw a blanket on those symptoms,” said Dr. Raymond Turpin, a psychologist with the nonprofit Pearl Psychedelic Institute in Waynesville. “Unfortunately, we haven’t done a very good job with those drugs.”
For years, Marine Jonathan Lubecky says his doctors worked with him trying to cure his PTSD and suicidal ideations.
“They had me on I think a total of 42 pills a day for mental health and chronic pain and stuff like that,” Lubecky said.
Three years later, Lubecky learned of a phase two MDMA trial in South Carolina run by a nonprofit called MAPS, the Multidisciplinary Association for Psychedelic Studies. Since 1986, MAPS has conducted research into legitimate medical uses for cannabis and psychedelics like Ketamine and MDMA.
MDMA is able to be used through “compassionate use.” That’s the term for FDA-approval when other options won’t work for patients.
“It kind of felt like I was in a tight wetsuit in a hot tub. It’s like doing therapy while being hugged by everyone in the world who loves you in a bathtub full of puppies licking your face,” he said.
After going through the trial, Lubecky said he’d experienced a miraculous recovery from his symptoms.
“Interestingly enough, I refratted from Iraq Nov. 22, 2006. I took my first dose of MDMA Nov. 22, 2014,’ he said. “That also means that on Nov. 22 of this year I will have been healed of PTSD as long as I had it.”
Turpin explained that MDMA effectively shuts down the brain’s fight-or-flight responses.
“When those go down, what that does is it allows the trauma material that's been improperly stored, it allows it to come into consciousness because that's one of the functions that the amygdala does is, it keeps all this stuff buried so that you can get out in your life,” he said.
The treatment consists of several orientation sessions, followed by three dosing sessions in a clinical setting, each of which are followed by further counselling sessions. When that trauma resurfaces, it can be processed properly.
“What successful trauma treatment can do is help people realize, these are terrible things that happen to you but they're really not who you are,” said Turpin. “That's what happens with MDMA, it basically takes this information, allows the client to sit with it, and then it allows it to go through the normal processing channels and be stored like a more normal memory.”
Results from phase two and phase three trials showed that after the doses, 67% of participants no longer show PTSD symptoms. That’s compared to antidepressant treatment which has a success rate of 50% at best, according to Turpin.
“There’s also a couple of hormones that get released, oxytocin and prolactin, they are oftentimes involved in empathy, compassion, deep states of relaxation and connection and so when you’re working in psychotherapy with a therapist it can kind of help the whole therapeutic process,” said Turpin.
The treatment takes between four to six months, and is monitored by therapists in a clinical setting. Turpin’s institute in Waynesville be the first in the country to offer the expanded access treatment, and three more sites across the nation are expected to follow soon.