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MAPS BULLETIN
MAPS Bulletin Summer 2014: Research Edition
 
Media > Recent and Archival
June 24, 2014

Boulder: Three More Subjects Enrolled; Study Size Increased to 23 Subjects

From June 20-24, 2014, the seventh, eighth, and ninth subjects were treated in our ongoing study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. Our application to increase the study size from 17 to 23 subjects was approved by the Institutional Review Board on May 6, and passed the Food and Drug Administration’s 30-day review period on June 1. We have increased the size of this study in order to get a better sense of the range of outcomes from different co-therapist teams—important data for calculating the size of our Phase 3 studies—and to compare the effectiveness of different doses of MDMA combined with psychotherapy for treating PTSD. 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. “I feel so blessed to have been in this study,” reported one female participant in an email. “I feel like I have access to much more of myself and the part of me that is healthy has become stronger.”



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