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A Psychedelic May Soon Go to the FDA for Approval to Treat Trauma
Key Excerpts from Article on Website of Scientific American
Posted: March 6th, 2022
https://www.scientificamerican.com/article/a-psychedelic-may...
Berra Yazar-Klosinski [is the] chief scientific officer at the Multidisciplinary Association for Psychedelic Studies (MAPS). I ... committed to working with her on the phase 3 program that would assess the efficacy and safety of MDMA—known recreationally as Molly or Ecstasy—for severe PTSD, or post-traumatic stress disorder. Although more than half a dozen phase 2 studies have demonstrated the effectiveness and safety of MDMA for PTSD, early trials often fail to accurately predict the outcome of the larger, multisite phase 3 trials that follow. In the case of MDMA, we have been lucky. At 15 study sites across three countries, working with more than 70 different therapists and with study participants with childhood trauma, depression and a treatment-resistant subtype of PTSD, we have obtained incredibly promising results. Phase 3 study participants receiving MDMA-assisted therapy showed a greater reduction in PTSD symptoms and functional impairment than participants receiving placebo plus therapy. In addition, their symptoms of depression plummeted. By the end of the study more than 67 percent of the participants in the MDMA group no longer met criteria for PTSD. An additional 21 percent had a clinically meaningful response—in other words, a lessening of anxiety, depression, vigilant mental states, and emotional flatness. MDMA-assisted therapy did not increase measures of suicidal thinking or behavior. MDMA also did not demonstrate any measurable misuse potential.
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