Amendment to Canadian MDMA Study Submitted to IRB

On Nov. 26, 2010, three days after MAPS’ clinical research submitted the amendment for our Vancouver study of MDMA-assisted psychotherapy for PTSD, it was approved by the Canadian Institutional Review Board. The amendment changes the protocol to align it with our other MDMA/PTSD studies and adds several new aspects, including: a long-term follow-up data collection point one year after the final experimental treatment session, a measure of suicidality as required by the U.S. Food and Drug Administration (FDA), a personality inventory, a new informed consent form, and video recording of the sessions. By aligning the new protocol with past studies, the amendment enables us to compare results side-by-side and conduct future meta-analyses. We’ve also recently heard back from Health Canada in response to our pharmacist’s Nov. 1 application to serve as the licensed provider of MDMA for the study. As the licensed provider, the pharmacist would be able to import MDMA from our supplier in Switzerland for the study. We were also informed of the type of safe and alarm systems that the pharmacist will be required to install for the MDMA. We will submit the protocol amendments to Health Canada after our pharmacist has received the import license. At this point we still cannot predict a start date, but we continue to be optimistic about starting in early 2011.