A club drug may be helping veterans and first responders get out of a club they never wanted to belong to. The results of a study just published in The Lancet Psychiatry show that when they were given MDMA, an ingredient in the drug known as Ecstasy or Molly, along with psychotherapy, their chronic post-traumatic stress disorder lifted in many cases.
Medical University of South Carolina faculty member Michael Mithoefer, M.D., led the study with his wife, nurse Ann Mithoefer, in their Mount Pleasant psychiatric clinic. None of the research was conducted on the MUSC campus.
“MDMA, the way we see it, is acting as a catalyst for psychotherapy,” Michael Mithoefer said. “It allows people to feel they can process their trauma without being overwhelmed by their anxiety. What we know from imaging data is that, very interestingly, MDMA decreases activity in the amygdala, the fear center of the brain, and it increases activity in the prefrontal cortex, which is kind of the higher processing center.”
He said the drug has a big effect on serotonin release and stimulation, norepinephrine, dopamine and oxytocin, all of which are involved in making people feel happy.
The study had 26 participants: 22 veterans, three firefighters and one police officer. Three of the veterans and two of the firefighters are from the Charleston area.
The participants were given MDMA in a clinical setting along with psychotherapy for their trauma in two daylong sessions. They spent the night afterward so they could be monitored.
The research was sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies and was regulated by the Food and Drug Administration. A report on it was published this week in the British journal Lancet Psychiatry.
The results of the trial were remarkable, Mithoefer said. Almost 70 percent of the people who got the full dose of MDMA being tested fared so well that they no longer met the criteria for post-traumatic disorder. Plans are now in the works for a larger phase 3 trial, which will be compare the MDMA-assisted psychotherapy with current standard treatments.
Mithoefer said if the MDMA therapy continues to do well in further testing, the FDA might make its therapeutic use legal within a few years. The FDA already granted the potential treatment breakthrough status last year. “That’s designed to expedite it,” Mithoefer said.
He got interested in finding new options for people for PTSD while doing his psychiatric residency at MUSC. “I saw that we needed better treatments. And I was aware there were some case reports about MDMA. It was used with therapy by maybe several thousand therapists and psychiatrists before it became illegal in 1985. A couple of the psychiatrists published case reports talking about how MDMA could help people not have so much fear of talking about their experiences.”
In 2004, he and his wife started the first-ever clinical trial to be completed testing MDMA as a treatment for PTSD. The participants were crime victims and the results were promising. Several other trials in Colorado, Vancouver, Switzerland and Israel followed, Mithoefer said.
His more recent trial focused mainly on veterans because their PTSD can be especially stubborn. Mithoefer said the participants were carefully screened.
“Like any drug, MDMA has risks as well as benefits. There’s some minor side effects that are very common like some muscle tension, and sometimes people feel quite tired the day after. Doing it in this controlled stetting, the main risk is that it does increase blood pressure and pulse significantly, kind of like vigorous exercise. We screen out people with cardiovascular disease and cerebrovascular disease. We want people to be quite medically healthy.”
Mithoefer said two colleagues at MUSC, Mark George and Colleen Hanlon, did a sub-study during the trial that involved getting magnetic resonance images before and after on some of the veterans. They’re still analyzing the results.
MDMA doesn’t erase trauma, Mithoefer said. It just makes it a little easier to handle. "People tend to say, 'This is still painful, but I feel like I can face it now without being overwhelmed by trauma and process it without emotional numbing or being overcome by anxiety.'"