A fateful step has been taken. Today, MAPS submitted Dr. John Halpern’s MDMA/cancer anxiety protocol and associated documents to the FDA. FDA should receive the protocol Monday, November 22 and will then have 30 days from that point to review it. FDA will either approve the protocol or place it on clinical hold pending resolution of any issues FDA felt it appropriate to raise. If approved by FDA, the last remaining major hurdle before the study can start will be Dr. Halpern’s need to obtain a DEA Schedule 1 license to dispense the MDMA to be used in the study. After FDA approval has taken place, we feel that DEA will most likely issue the license sooner rather than later, probably voluntarily. DEA cooperation will be due to the compelling nature of this study, the amount of existing interest and support, the very low risk of diversion since there are no “take-home” doses, and, most importantly, the regulatory limits on the factors that DEA can use to evaluate applications for Schedule I licenses to conduct FDA-approved research. If fully approved, this study will become the first psychedelic research to take place at Harvard since 1965. A new era will then have begun in earnest 21st Century psychedelic research!
