The Institutional Review Board (IRB) reviewing Dr. Mithoefer’s MDMA/PTSD protocol made its final decision — and approved the study! This is a historic moment for MAPS and for MDMA research. The approval marks the end of a three-month process with this IRB, and a 22-month IRB process overall. Dr. Mithoefer and MAPS have been struggling to obtain IRB approval since November 2001, when the FDA approved the study.
This is the eighth IRB to which we’ve tried to submit the protocol. Five refused to accept it for review (after varying periods of consideration), one approved it then revoked that approval for political reasons, and another finally tabled the review, after spending months formally reviewing the study before making it clear, through unreasonable demands, that the committee did not want to approve it. Along the way, we also established a MAPS IRB, but fortunately, we didn’t need to use it.
The last remaining step before we can begin the study is for Dr. Mithoefer to obtain a DEA Schedule I license. DEA received Dr. Mithoefer’s application more than 15 months ago. We hope to receive a license somewhat quickly now that IRB approval has been obtained, but you can never tell with DEA. After Dr. Mithoefer does obtain a Schedule I license, we can finally begin the study of MDMA-assisted psychotherapy in subjects with chronic Posttraumatic Stress Disorder (PTSD).
