MAPS Researchers Michael Mithoefer, M.D., Ilsa Jerome, Ph.D., Amy Emerson, Valerie Mojeiko, and Rick Doblin Ph.D. had a second teleconference about our MDMA-therapist training protocol with officials in the FDAs Division of Psychiatric Products. The FDA requested that we add additional psychiatric measures for pre-and post-MDMA administration and that we design the study with a double-blind, placebo-controlled methodology. The alterations to the protocol will more rigorously examine the psychological effects of MDMA on healthy volunteers. We will be permitted to limit subjects to the therapists in our training program who will conduct Phase 2 and Phase 3 MDMA/PTSD studies. Our research team is in the process of modifying the protocol according to the FDAs requests and will be submitting a new version within the next week. We expect to obtain approval from FDA upon our next submission and will then submit the protocol to our Institutional Review Board.
