On May 20, 2011, the first subject was unblinded in our ongoing US Phase 2 study of MDMA-assisted psychotherapy for PTSD in veterans of war. Now that the research team knows which dose of MDMA the subject received (low, medium, or high), they can determine whether the subject is eligible to participate in Stage 2 of the study or continue on to the long-term follow-up portion of the study. Stage 2 involves giving the subject an additional MDMA-assisted psychotherapy session, and is reserved for those subjects who received either low (“active placebo”) or medium dose of MDMA in Stage 1 in order to provide all subjects with the same opportunity to experience the effects of a full dose. If the subject received a full dose of MDMA, they will advance to the long-term follow-up portion of the study in which treatment effects (if any) are evaluated 12 months following treatment by the re-administration of the Clinician Administered PTSD Scale (CAPS). This study is our first to compare the safety and effectiveness of three (rather than two) different doses of MDMA in combination with psychotherapy. All MAPS MDMA/PTSD studies with the exception of our completed Phase 2 pilot study have used active placebos in order to effectively maintain the study blind.
