Oct. 30, 2018 -- The long-banned “club drug” MDMA showed strong results as a treatment against posttraumatic stress disorder in its largest and longest study to date, researchers reported Monday.
The phase II clinical trial followed 28 patients with chronic PTSD, including military veterans and crime victims, who took the drug during three daylong psychotherapy sessions over 3 months. After two sessions, 43% of the group that received active doses of MDMA no longer met the definition of PTSD, compared to 33% who got a low dose of the drug as a placebo. And a year after the first session, 76% of the active-dose group no longer had PTSD, according to results published in the Journal of Psychopharmacology.
The long-term results are better than those seen in previous MDMA studies, says Brad Burge, a spokesman for the Multidisciplinary Association for Psychedelic Studies, which funded the research.
“That efficacy actually increases the more time passes,” Burge says. “That’s absolutely remarkable, especially when compared to traditional treatments where people have to take drugs for months or years, or for the rest of their lives, to see any benefit at all.”
Doctors diagnose posttraumatic stress disorder in people who’ve experienced a life-threatening event by looking at a battery of symptoms, including nightmares, flashbacks, or feelings of depression. These new results don’t mean that all the problems associated with participants’ PTSD have gone away, “but they don’t qualify for a diagnosis of PTSD anymore,” Burge says.
MDMA is the active ingredient in what’s commonly known as “ecstasy” or “Molly.” It was invented in 1912 as a way to help produce drugs that controlled bleeding. But starting in the 1970s, psychiatrists found it enhanced communication with patients. By the mid-1980s, it was becoming widely abused, and the U.S. government banned it in 1985.
The latest MDMA study, conducted at a private clinic in Boulder, CO, produced no serious adverse events related to the drug. MDMA can cause the heart to race and blood pressure to jump, but the participants handled the drug well, the researchers report.
Researchers have been giving MDMA and other hallucinogenic drugs a second look for a variety of hard-to-treat mental health issues in recent years. The shift in thinking is significant as not only did the federal government classify these drugs as having no acceptable medical uses and a high potential for abuse, but many researchers believed they were too powerful to use therapeutically. But many officials and researchers now believe the mental health field is facing “a moment of great need” that’s prompted some rethinking.
The FDA last week granted “breakthrough therapy” status to another long-banned drug, psilocybin -- the active ingredient in psychedelic mushrooms -- as a potential therapy for treatment-resistant depression.
COMPASS Pathways, the U.S.-U.K. consortium behind the psilocybin research, says it plans to conduct the first large-scale psilocybin therapy trial over the next year.
“The breakthrough therapy designation is a strong endorsement for the potential of psilocybin therapy,” Robin Carhart-Harris, MD, head of the Psychedelic Research Group at Imperial College London, says in a statement announcing the move. “We look forward to learning more as further clinical studies are carried out, by our team at Imperial College as well as in COMPASS's multi-center trial."
Breakthrough designation is granted to drugs that show “substantial improvement” in clinical studies over existing treatments for serious conditions, such as depression. Earlier research led by Johns Hopkins University concluded that psilocybin showed promise in fighting anxiety and depression in patients with life-threatening cancer, raising the prospect that it could help relieve those conditions where conventional antidepressants have had little effect.
“For the second time in a year, we have the FDA determining that a psychedelic-assisted therapy could be a significant advance over what’s currently available for mental health treatment,” Burge says. “That’s very different from the last 40 years of regulatory, political and cultural attitudes around these drugs.”
Regulators named MDMA a breakthrough therapy in 2017, which could put it on the fast track to approval if an upcoming phase III trial produces positive results.
“It’s been decades since psychiatry has had a new set of tools available to it,” Burge says. “And here we have psychedelics entering as a whole new class of pharmaceuticals that when used in combination with psychotherapy, could actually be better than conventional treatments.”