Mithoefer Receives DEA License for Phase 1 Psychological Effects/Therapist Training Study; License for U.S. MDMA/PTSD Veterans Study Coming Soon

On August 9, Michael Mithoefer, M.D., received a Schedule I license from the Drug Enforcement Administration (DEA) to administer MDMA in our Phase 1 study to investigate the effects of MDMA on healthy volunteers (limited to thera- pists enrolled in our therapist-training program). He waited approximately seven months to receive the license. This is a relatively short period compared with 19 months last time he was licensed. The DEA also told Dr. Mithoefer to expect his license for our Veterans study soon, which would be only 4 months from the time of application. The FDA and Institutional Review Board (IRB) approved both of these studies months ago, so we’ve just been waiting on the DEA’s Office of Drug and Chemical Evaluation (ODE) to issue the licenses. The studies are co-lead by Ann Mithoefer, B.S.N.