In 2021, researchers at the University of California, San Francisco published results from a Phase 3 trial testing MDMA combined with psychotherapy in ninety adults with severe, chronic PTSD.
Half the participants received MDMA before three therapy sessions, half received the same therapy with a placebo. Eighteen weeks later, 67 percent of the MDMA group no longer met the clinical criteria for PTSD, compared with 32 percent of the placebo group.
The trial, run across fifteen sites with Rick Doblin's MAPS as sponsor, was the largest psychedelic therapy study completed to that point. A second trial replicated the result in 2023. But in 2024 the FDA rejected the treatment for approval, citing concerns about blinding, since most participants could tell whether they had received MDMA, and it requested further research.
Read the original study
Mitchell et al., Nature Medicine, 2021 · doi.org/10.1038/s41591-021-01336-3
Sixty seven percent recovered. The FDA still said no.
Source
- Mitchell, J. M., Bogenschutz, M., Lilienstein, A., Harrison, C., Kleiman, S., Parker-Guilbert, K., Ot’alora G., M., Garas, W., Paleos, C., Gorman, I., Nicholas, C., Mithoefer, M., Carlin, S., Poulter, B., Mithoefer, A., Quevedo, S., Wells, G., Klaire, S. S., van der Kolk, B., . . . Doblin, R. (2021). MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine, 27(6), 1025–1033. https://doi.org/10.1038/s41591-021-01336-3