Results from a Phase III trial released this week could soon usher in a new era for the treatment of post-traumatic stress disorder. The study found that a combination of MDMA and psychotherapy was effective in reducing PTSD symptoms compared to standard therapy. The nonprofit organization funding this research now plans to seek formal approval of the MDMA-assisted therapy from the Food and Drug Administration before the end of the year.
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MDMA is short for 3,4-methylenedioxy-methamphetamine. It is a synthetic drug with both stimulant and psychedelic effects. In the past it was used as a recreational drug under the nickname Molly or Ecstasy. And it has been classified as an illegal controlled substance by the U.S. federal government since the 1980s. But for decades, some psychologists and researchers have experimented with using MDMA as a way to increase the effectiveness of psychotherapy, particularly for post-traumatic stress disorder.
This once nascent movement has gained significant momentum in recent years thanks to promising, albeit smaller, research and studies. changing social attitudes associated with the legalization of many illegal drugs. Much of this research was funded and organized by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit advocacy group. More recently, MAPS successfully submitted an application to the FDA to consider approval of an MDMA-assisted therapy for PTSD. FDA approval of a new use of a drug typically depends on positive data from at least two larger Phase III trials, data that now appears to be available for MDMA-assisted therapy.
This new study was published Thursday in the journal Nature Medicine. The study involved more than 100 people with moderate to severe post-traumatic stress disorder who were randomized into two groups: one group. who received standard therapy and the others who received therapy plus MDMA. Both groups received three sessions each and were followed for 18 weeks.
At the end of the study period, researchers found that, on average, those who received MDMA-assisted therapy fared better than the control group. About 86% of the MDMA group achieved a “clinically significant” improvement in their symptoms compared to 69% of the control group, as measured by a standard PTSD measurement scale. And 71% of the former group improved enough to no longer meet criteria for active PTSD, compared to 48% of the latter. No major safety problems were identified with MDMA use, although common side effects included muscle tension, nausea and sweating.
The new results are consistent with results from the first MAPS-funded Phase III study, also published in Nature Medicine in 2021. But unlike the first, the new study was able to include a more diverse group of participants at this point. an important consideration for the approval of a new drug or therapy. Although not everyone appears to respond to MDMA-assisted therapy, the treatment could provide a valuable new option for people who have not responded to existing medications or therapies.
Given the promising results, it is very likely that the FDA will approve MDMA-assisted therapy for post-traumatic stress disorder. According to the AP, additional logistical hurdles may need to be overcome before this treatment can be widely prescribed to patients. MDMA is currently classified by the Drug Enforcement Administration as a Schedule I controlled substance, a designation for drugs believed to have strong effects. Possible misuse and not accepted medical use.
MAPS is continuing its application and plans to seek formal FDA approval before the end of 2023. If successful, MDMA-assisted therapy could be available to the public as early as next year.
“We hope that MDMA-assisted therapy for PTSD will be approved by the FDA next year and that our open science and open books principle will inspire researchers to make this just the first of many psychedelic-assisted therapies.” “Be validated through careful research,” said Rick Doblin, founder and president of MAPS, in a statement from the organization.
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