The 10th subject had her 2nd experimental session, which went well. Once she completes her final follow-up evaluation in about two months, we will have completed half of Stage 1 of the study. We’ll then conduct a preliminary data analysis and submit it to MAPS’ Data Safety Monitoring Board (DSMB) for review. There have been no Serious Adverse Events (SAEs) during the first half of our study and the outcome data looks promising.
Stage 2 is for those subjects who received placebo and wish to reenroll in the study to receive MDMA “open-label.” The second subject in Stage 2 is scheduled to receive her second MDMA session on Monday, August 1. This session will also be used as a training session for Drs. Halpern and Naidoo from Harvard Medical School. They have the subject’s permission to observe in order to help them prepare to conduct their MAPS-sponsored study of MDMA in subjects with anxiety associated with advanced-stage cancer. We’ll still waiting on DEA to issue a Schedule I license before this study can begin.