U.S. Veterans Study: Recruiting Subjects; Awaiting DEA Review

We are now in the process of recruiting subjects for our study of MDMA-assisted psychotherapy for veterans with war-related PTSD. We are mostly seeking veterans from Iraq and Afghanistan but are looking for a few from Vietnam as well. The study, to be conducted by Michael Mithoefer, M.D. and co-therapist Ann Mithoefer, B.S.N., will be our second MDMA/PTSD study to take place in Charleston, SC. The Mithoefers’ previous study of MDMA-assisted psychotherapy included subjects whose PTSD was primarily the result of sexual assault, abuse and violent crime, with just two veterans with war-related PTSD. This new study will only enroll veterans with war-related PTSD. We will also be able to enroll subjects with the previously excluded risk factors of Hepatitis C or controlled hypertension, with additional screening evaluations and safety measures for these subjects.

The final hurdle before the study is able to move forward is that Dr. Mithoefer must obtain a renewed Schedule I license to handle the MDMA required for the study. He has already been waiting over 3 months on the DEA’s Office of Drug and Chemical Evaluation (ODE) to complete its review of his license application, which he submitted after obtaining both FDA and IRB permission. Unlike the FDA, the DEA has no time limits for issuing licenses. The ODE informed us on July 13 that the review could take an additional four months or more, meaning we may have to wait until October to start the study unless we can find a way to motivate the DEA to move faster. President Obamas announcement on July 11 that it is a national priority to expedite treatment to veterans with PTSD may prove helpful.