MDMA Research Update: June 2006

Dr. Michael Mithoefer has received Institutional Review Board (IRB) approval for several key changes that FDA had recently approved to his MAPS-sponsored study evaluating MDMA-assisted psychotherapy as a treatment for PTSD. The changes include (1) adding a third experimental session to the two that are currently included in the protocol to test whether a third session adds significantly to the therapeutic process, (2) providing supplemental dosing of half the initial amount of MDMA administered 2 to 2.5 hours after the initial dose in order to prolong the plateau of MDMA’s therapeutic effectiveness, and (3) doing without an ER doctor on standby in the next room since Dr. Mithoefer has become a board-certified ER doctor as well as a board-certified psychiatrist. Now that the Data Safety Monitoring Board (DSMB), FDA, and IRB have all approved these changes to our protocol, they will be implemented for the study’s remaining eight subjects.