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Oct. 30, 2018 – The largest and longest and longest study to date on MDMA, the long-banned "club drug", has shown strong results, researchers reported on Monday.
The Phase II clinical trial followed 28 patients with chronic PTSD, including veterans and victims of crime, who had taken the drug over three sessions of psychotherapy of a duration three days each. After two sessions, 43% of the group who received active doses of MDMA no longer met the definition of PTSD, compared to 33% who received a low dose of the drug in the form of placebo. And one year after the first session, according to the results published in the Journal of Psychopharmacology, 76% of the group receiving the active dose no longer suffered from PTSD.
The long-term results are better than those seen in previous studies on MDMA, says Brad Burge, spokesperson for the Multidisciplinary Association of Psychedelic Studies, which funded the research.
"This efficiency actually increases as time goes on," says Burge. "This is absolutely remarkable, especially compared to traditional treatments in which people have to take medication for months or years, or for the rest of their lives, to see the benefit."
Physicians diagnose post-traumatic stress disorder in people who have experienced a life-threatening event by examining a battery of symptoms, including nightmares, flashbacks, or feelings of depression. These new findings do not mean that all of the participants' PTSD problems have disappeared, "but they are no longer qualified for a diagnosis of PTSD," says Burge.
MDMA is the active ingredient in what is commonly known as "ecstasy" or "molly". It was invented in 1912 to stimulate pharmaceutical production, but from the 1970s, psychiatrists found that it improved communication with patients. In the mid-1980s, it was widely used and the US government banned it in 1985.
The latest MDMA study, conducted in a private clinic in Boulder, CO, did not result in any serious adverse events related to the drug. MDMA may cause heart racing and blood pressure, but participants handled the drug well, the researchers reported.
Researchers recently examined MDMA and other hallucinogenic drugs to address a variety of difficult mental health issues. The change in mentality is significant because not only has the federal government clbadified these drugs as having no acceptable medical use and presenting a high abuse potential, but many researchers have felt that they were too much powerful to be used for therapeutic purposes. But many leaders and researchers now believe that the field of mental health is facing a "time of great need" that has prompted rethinking.
Last week, the FDA granted "disruptive therapy" status to another long-banned drug, psilocybin – the active ingredient in psychedelic mushrooms – as a potential treatment for refractory depression.
COMPASS Pathways, the US consortium behind psilocybin research, has announced plans to conduct the first large scale trial of psilocybin therapy over the next year.
"The innovative therapy designation is a strong support for the potential of psilocybin," said Robin Carhart-Harris, head of the psychedelic research group at Imperial College London, in a statement. "We look forward to learning more as more clinical studies are conducted by our team at Imperial College as well as in the multicenter COMPASS trial."
The revolutionary designation is given to drugs that demonstrate "substantial improvement" in clinical studies over existing treatments for serious conditions, such as depression. Previous research conducted by Johns Hopkins University has found that psilocybin is promising in the fight against anxiety and depression in patients with life-threatening cancer, highlighting the potential for relieving clbadic antidepressants had little effect.
"For the second time in a year, the FDA has determined that psychedelic-badisted therapy could be a significant step forward from what is currently available for mental health treatment," says Burge. "This is very different from the last 40 years of regulatory, political and cultural attitudes around these drugs."
Regulators have designated MDMA as a breakthrough therapy in 2017, which could be quickly approved if a next phase III trial produced positive results.
"Psychiatry has had a new set of tools for decades," says Burge. "And here we have psychedelics entering a whole new clbad of pharmaceuticals that, used in combination with psychotherapy, might actually be better than conventional treatments."
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