Boulder: Three More Subjects Enrolled; Study Size Increased to 23 Subjects
On May 27, 2014, the sixth, seventh, and eighth subjects were enrolled in our ongoing study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. One subject voluntarily withdrew from the study following their first experimental session on May 2. Two subjects have now dropped out of this study. (Note: We are now subtracting dropouts from the total enrolled to more accurately reflect study progress.) On May 15, the Institutional Review Board approved our amendment to increase the size of the study from 17 to 23 subjects. The U.S. Food and Drug Administration 30-day review period passed on June 1, enabling us to go forward with the amendment. We will also need approval from the Drug Enforcement Administration for the additional MDMA needed. 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. This study is also testing the use of interns as one half of our male/female co-therapist teams.