U.S. Veterans Study: Awaiting FDA’s Controlled Substance Staff to Approve Researcher and Protocol

Our study of MDMA-assisted psychotherapy for the treatment of PTSD in veterans of war is waiting for the FDA’s Controlled Substances Staff (CSS) to complete its review of the qualifications of the investigator (Michael Mithoefer, M.D.) and to evaluate the protocol from a diversion control perspective. Since Dr. Mithoefer held a DEA Schedule 1 license for our flagship MDMA/PTSD study and conducted an excellent study with all MDMA properly accounted for, the review by the CSS will almost certainly be favorable. Unfortunately, there is no time limit on how long the CSS can take to review protocols, so we can only wait for CSS to focus on our study. After the CSS approves the investigator and protocol, then the DEA must renew the Schedule 1 license of MAPS’ lead investigator Michael Mithoefer, M.D. and give him permission to order more MDMA for the new study. We hope to start this study soon.