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

ABSTRACT: Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinic

SUBMITTER: Mitchell JM 

PROVIDER: S-EPMC8205851 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature