Boulder: Last Subject Receives Final Experimental Treatment

On December 4, 2015, the last subject received their final experimental treatment in our Phase 2 study of MDMA-assisted psychotherapy for 23 subjects with chronic, treatment-resistant PTSD. This study has enrolled a total of 29 subjects, with six dropouts. Each participant who completed this study received three experimental MDMA-assisted psychotherapy sessions along with multiple preparatory and integrative psychotherapy sessions. Primary outcome data is collected four weeks following each subject’s second session, when the subjects and therapists are unblinded. Subject scores on the Clinician Administered PTSD Scale (CAPS) following the unblinded third session will not be included in the primary statistical analysis, and is intended to provide additional data to guide the design of our upcoming Phase 3 trials. “For the first time in my life, I was able to face my worst fears and memories with the quiet knowledge that they could no longer reach out and destroy me,” reports Hania Sakal, who participated in the trial. “The certainty was absolute: with the help of MDMA and the therapists who were there to witness and guide my journey, I was safe from harm and from the people in my past who no longer had the power to hurt me.” The final results will begin to be prepared for publication in early 2016, with publication expected in late 2016.