On December 18, all the documents for our Canadian study of MDMA-assisted psychotherapy in the treatment of people with Posttraumatic Stress Disorder (PTSD) were submitted to Health Canada (Canada’s version of the FDA). We’ve already obtained approval of our protocol and informed consent from a Canadian Institutional Review Board. We should receive a reply from Health Canada within 30 days of our submission.
This is going to be a study with 12 subjects, similar in design to the recently completed US MDMA/PTSD study. Our main purpose for this particular study is to see if we can replicate the results of the US study. The budget for this study is $250,000, all of which remains to be raised.