On February 10, 2012, MAPS’ clinical team submitted a protocol amendment to the FDA with several important changes to our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with chronic, treatment-resistant PTSD. We’ve decided to increase the size of study from 16 to 24 subjects, enhancing the statistical power of the study and enabling us to make more conclusive observations about the therapeutic effectiveness of MDMA-assisted psychotherapy in veterans with service-related trauma. We hope that investigating a treatment for this especially vulnerable group will eventually lead to research funding from the U.S. Department of Defense and/or the Veterans Administration.
The amendments include the added possibility of enrolling firefighters and police officers suffering from PTSD as a result of their service. The addition of these subjects will increase local recruitment and reduce study costs, and will provide further evidence of MDMA-assisted psychotherapy’s effectiveness for an important social group. The study design has also been changed to make the post-second session outcome assessment the primary endpoint for the study. PTSD symptoms will now be assessed after the second experimental MDMA-assisted psychotherapy session rather than the third, as in our upcoming Israeli and Australian studies. This will enable us to conduct a more accurate comparison of results across our international research sites, and to help clarify whether the best treatment model involves two or three experimental MDMA-assisted psychotherapy sessions. The sixth subject in this study was enrolled on January 12.