U.S. Veterans Study: Sixth Subject Treated, Protocol Amendments Accepted

On February 25, 2012, the sixth subject was treated in our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with PTSD. The fourth protocol amendment (PDF) for this study received “unconditional approval” from the Institutional Review Board on February 22. The FDA has until March 10 to complete its own review. The amendments include expanding the study from 16 to 24 subjects, adding the possibility of enrolling local firefighters and police officers with work-related PTSD, and changing outcome assessment procedures to enable more exact comparisons with other studies. The clinical team is now working on incorporating the amendments into study documents. We have raised the funds for the initial 16 subjects and are now developing the budget for the additional eight subjects.