Pilot Study: 13th Subject Receives First Treatment

Dr. Michael Mithoefer initiated the first experimental MDMA-assisted psychotherapy session with the 13th subject out of 20 in his MAPS-sponsored FDA Phase II pilot study. This subject was the first to receive 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, a change recently approved by Dr. Mithoefer’s Istitutional Review Board (IRB), the Food and Drug Administration (FDA), and the Data Safety Monitoring Board (DSMB). The supplemental dose did not seem to intensify the already strongly therapeutic experience but it did prolong the period of maximum therapeutic effect for at least 90 minutes. This appeared to be very useful. We were also happy to see that, as expected, there was no problem with vital signs.