Original title: MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study
The trial compared therapy paired with MDMA to the same therapy paired with an inactive placebo. Ninety people with severe PTSD were assigned to one of the two groups. Both groups had preparation and follow-up therapy sessions, and researchers measured symptoms and daily-life difficulties after treatment. PTSD symptoms fell more in the MDMA group, and daily-life difficulties also decreased more. The study tracked unwanted effects and suicidality during the trial.
Imagine two people following the same plan to get through a difficult week, with one getting an extra aid and the other getting a harmless substitute. Both follow the plan, but the person with the aid has a bigger reduction in the difficulties they face. In this paper, the shared plan is therapy, the aid is MDMA, and the substitute is placebo; the researchers compare changes in PTSD symptoms and daily-life difficulties.
Severe PTSD can disrupt daily life, and existing treatments are only modestly effective. In this trial, people who received MDMA alongside therapy had fewer PTSD symptoms and less functional impairment than people who received the same therapy with placebo.
The abstract reports outcomes at two months after the final experimental session in 90 participants. It does not establish how long the benefits last, how the treatment compares with other active treatments, or whether the findings apply beyond the people and conditions studied. It also does not provide detailed rates for individual adverse events.
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MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study — Jennifer Mitchell, Michael P. Bogenschutz, Alia Lilienstein et al. — Nature Medicine — doi:10.1038/s41591-021-01336-3
Abstract licence: CC BY
Explanation generated by Synthesis from the abstract — it is not the original paper.