MDMA-assisted therapy has shown promise in alleviating symptoms of post-traumatic stress disorder (PTSD), as per a recent study published in Nature Medicine. The study was conducted by MAPS Public Benefit Corporation, a company dedicated to developing prescription psychedelics. MAPS plans on submitting the study results to the Food and Drug Administration (FDA) as part of their application to market MDMA as a treatment for PTSD alongside talk therapy.
According to the senior author of the study, Berra Yazar-Klosinski, if approved, MDMA-assisted therapy would be the first new treatment for PTSD in over two decades. This offers hope to the approximately 5 percent of the adult population in the United States who suffer from PTSD each year. Traditional therapies and medications only prove effective in about 50 percent of patients.
Dr. Stephen Xenakis, an executive director of the American Psychedelic Practitioners Association, expressed the urgent need for alternative treatment options. He stated that many individuals suffering from PTSD become hopeless with conventional therapies and often contemplate suicide. MDMA-assisted therapy, when administered properly and professionally, could potentially save lives.
MDMA, also known as Ecstasy or Molly, has been classified as an illegal substance since 1985. However, prior to that, it was widely used by therapists for various purposes, including couples counseling and addressing trauma. Founder of MAPS, Rick Doblin, expressed regret that the criminalization of MDMA in the 1980s hindered its potential as a therapeutic tool.
MAPS has been advocating for the legalization of MDMA-assisted therapy since 1986 and supporting research on its efficacy in treating PTSD since 2001. The FDA granted “breakthrough therapy” status to MDMA-assisted therapy for PTSD in 2017. This designation expedites the development of promising experimental drugs. Psilocybin-assisted therapy for treatment-resistant depression also received breakthrough status in 2018.
The recent study included 104 participants diagnosed with moderate to severe PTSD, and who had been living with the condition for an average of 16 years. The participants underwent three preparatory talk therapy sessions followed by three treatment cycles. Each cycle consisted of an eight-hour session in which the patient received either MDMA or a placebo alongside talk therapy, followed by three additional talk therapy sessions.
The study found that participants who received MDMA experienced significantly greater reductions in PTSD symptoms compared to those who received a placebo. By the end of the study, 86.5 percent of individuals who received MDMA achieved a measurable reduction in symptom severity, with 71 percent no longer meeting the criteria for a PTSD diagnosis. In contrast, 69 percent in the placebo group improved, with nearly 48 percent no longer qualifying for a PTSD diagnosis.
The study results were similar to those of the first Phase 3 study on MDMA-assisted therapy for PTSD published in 2021. It is worth noting that the most recent study had a more diverse participant pool, which is a significant improvement. The study included a greater representation of Hispanic, Latino, and nonwhite individuals.
MAPS PBC has been working closely with the FDA to ensure the safety and efficacy of MDMA-assisted therapy. They are currently conducting a follow-up study to examine the long-term effects of this treatment. If approved, MAPS PBC plans to submit a new drug application to the FDA.
While some experts have expressed skepticism about the study’s results meeting FDA approval criteria, proponents of MDMA-assisted therapy argue that alternative treatment options are necessary, especially considering the current inadequacy of available treatments for PTSD. Increasing options for patients should be the primary focus for healthcare professionals, rather than adhering to a scarcity mindset.
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