A Randomized, Double-Blind, Controlled Phase 2 Pilot Study of Manualized 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in 12 Subjects With Treatment-Resistant Posttraumatic Stress Disorder (PTSD) – Canada
This Canadian pilot study was a randomized, double-blind, placebo-controlled evaluation of MDMA-assisted therapy designed to treat 12 patients with chronic, treatment-resistant PTSD. This study was intended to obtain estimates of effect size for safety and efficacy. Participants were randomized to receive either a full therapeutic dose of MDMA or inactive placebo during the blinded part of the study. PTSD symptoms and cognitive function was assessed at baseline and one month after the second Experimental Session of MDMA-assisted therapy. Full dose participants continued in Stage 1, receiving another full dose Experimental Session. The benefits of two versus three Experimental Sessions were to be assessed. Participants assigned placebo during Stage 1 of this study had the option to crossover into Stage 2 and receive three sessions of MDMA-assisted therapy. Six participants started treatment, but this study was terminated early by the sponsor due to insufficient rate of accrual and incomplete data collection.