Boulder: Sixth and Seventh Subjects Treated, Amendment Submitted to FDA and IRB
On April 18, 2014, the sixth subject was treated in our ongoing study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The seventh subject was enrolled on March 27, and received the first MDMA-assisted psychotherapy session on May 2. Additionally, on May 1, we submitted a revised protocol for review to the Institutional Review Board proposing to increase the study size from 17 to 23 subjects , and on May 2 we submitted the revised protocol to the U.S. Food and Drug Administration. This study is investigating the safety and effectiveness of MDMA-assisted psychotherapy for subjects with chronic, treatment-resistant PTSD resulting from sexual assault, violent crime, war, or any other cause.