A randomized, double-blind, placebo-controlled Phase 3 study. Research by: Jennifer M. Mitchell, Michael Bogenschutz, Alia Lilienstein, Charlotte Harrison, Sarah Kleiman, Kelly Parker-Guilbert, Marcela Ot’alora G., Wael Garas, Casey Paleos, Ingmar Gorman, Christopher Nicholas, Michael Mithoefer, Shannon Carlin, Bruce Poulter, Ann Mithoefer, Sylvestre Quevedo, Gregory Wells, Sukhpreet S. Klaire, Bessel van der Kolk, Keren Tzarfaty, Revital Amiaz, Ray Worthy, Scott Shannon, Joshua D. Woolley, Cole Marta, Yevgeniy Gelfand, Emma Hapke, Simon Amar, Yair Wallach, Randall Brown, Scott Hamilton, Julie B. Wang, Allison Coker, Rebecca Matthews, Alberdina de Boer, Berra Yazar-Klosinski, Amy Emerson and Rick Doblin
SUMMARY
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. Participants were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. The results indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation.
This study is the first Phase 3 study involving MDMA and was a huge collaborative effort from the Multidisciplinary Association for Psychedelic Studies (MAPS) team and their public benefit corporation.
IMPLICATIONS
This study is exciting because of the potential future impact this inevitably will have on the legalization of MDMA for controlled, medical use. For me, and for many that have taken MDMA, the experience of taking MDMA is a way to alter your state of mind and elevate feelings of empathy, emotional warmth and an enhanced sense of well-being
While taking MDMA for purposes like leadership development, understanding critical race theory, or simply for recreation and the pursuit of happiness may still be many years to come, the implications of this study presents MDMA as a medicine, not as a "harmful party drug" that has no medical purpose.
In its application to treat PTSD, MDMA allowed for participants to be more willing to discuss emotionally-charged memories, ideas and beliefs. These are critical mindsets to adopt when having difficult DEI discussions in the workplace, and I hope MDMA-assisted DEI training is no longer just a dream.
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