Research library / Clinical trial

MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study

Mitchell JM, Bogenschutz M, Lilienstein A, et al. Nature Medicine 2021;27(6):1025-1033

This phase 3 trial tested MDMA-assisted therapy in 90 people with severe PTSD, many of whom also had depression, dissociation, past substance problems or childhood trauma. Everyone came off psychiatric medication first, then received three drug sessions with either MDMA or a placebo, wrapped in the same course of talking therapy. Two months after the last session, PTSD symptoms had fallen considerably more in the MDMA group, and day-to-day functioning had also improved more. The researchers did not see signs of abuse potential, increased suicidality or heart-rhythm problems from MDMA. Because both groups got substantial therapy, the result speaks to what MDMA adds on top of that therapy. The follow-up here is short, and keeping participants unaware of whether they had MDMA is hard with a drug this noticeable.