Objective: New data from a previously published randomized blinded Phase II clinical trial (Mithoefer, et al., 2011) is presented here to test whether psychological change mediates the effect of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for chronic, treatment-resistant PTSD. Method: Twenty-three (23) subjects with treatment-refractory PTSD were randomized to either a placebo or experimental condition. Subjects received 2-3 experimental sessions of 125 mg MDMA-assisted psychotherapy (N = 12) or inactive placebo and psychotherapy (N = 8) according to FDA/IRB approved protocol. The CAPS and NEO PI-R were primary outcome measures. Results: There was a significant main effect of decreased CAPS scores, independent of treatment condition when Openness F(1, 17) = 40.60 p < .001 or Neuroticism F(1, 17) = 20.48, p < .001 were used as covariates. Significant interactions showed that experimental subjects experienced the greatest increase in Openness, concomitantly demonstrating greater decreases in CAPS score, F(1, 17) = 5.68, p = .029;...

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