The Phase 3 trial, which was led by Professor Jenny Mitchell, could have dramatic effects for PTSD sufferers.
New psychedelics research led by Professor Jenny Mitchell, a BCSP-affiliated researcher, has shown that MDMA-assisted therapy can lead to a significant and dramatic reduction in symptoms for people who have PTSD (post-traumatic stress disorder).
The findings of the Phase 3 trial were published in the prestigious journal Nature Medicine last month. The results are the final research step before MAPS (the Multidisciplinary Association for Psychedelic Studies), which sponsored the trial, can submit a new drug application to the Food & Drug Administration (FDA) in the U.S. If approved by the FDA, the psychedelic drug MDMA could become available to many PTSD sufferers across the U.S., where around 5 percent of the population is estimated to have the condition. It would be one of the most significant shifts in psychedelics policy anywhere in the world.
Jennifer Mitchell is UCSF Professor of Neurology and also supports the psychedelics research program at UC Berkeley. In the study, she and her colleagues randomly gave 104 participants with PTSD either MDMA-assisted therapy, or therapy alongside a placebo drug; neither the participants nor the researchers knew whether a participant was in the MDMA group or placebo group. 85.5 percent of those in the MDMA group achieved a measurable reduction in severe PTSD, compared to 69 percent in the placebo group.
The study confirms previous findings in a study also led by Professor Mitchell, which was published in 2021. The participants in the latest study were purposefully more ethno-racially mixed, with 27 percent identifying as Hispanic/Latino and 34 percent identifying as other than white, to more accurately represent the potential treatment population for PTSD.
Imran Khan, executive director of the BCSP, said: “This new research is a momentous step forward for psychedelic science. It confirms that psychedelic-assisted therapy has tremendous potential to benefit people. We’d encourage those who’d like to learn more to take our free BCSP online course, Psychedelics and the Mind, which features Professor Mitchell in our module on MDMA.”