The Institutional Review Board that is reviewing our Canadian MDMA/PTSD study sent us a letter dated September 16, 2008, requesting a few changes to the protocol we submitted. We were delighted to receive this letter since it is clear now that the study itself will be approved. The IRB has some issues of concern that need a further exchange of information before being resolved.
The issues of concern relate to the open-label stage 2 portion of the protocol, the age of enrollment, and prior substance-abuse history of subjects. In addition, the Canadian IRB stated that our informed consent form was too long and detailed for subjects to fully comprehend and needed to be significantly shortened. This is in stark contrast to our United States IRB, which wanted an exhaustive informed consent form. The US form was so long that we instituted a non-graded quiz at the end to make sure that the subjects understood the nature of the risks of MDMA-assisted psychotherapy and the key elements of the study design.
We are gathering letters of support for the Canadian protocol from various experts, and will respond soon to the IRB’s concerns. Once the IRB approves a final version of the protocol and informed consent, we will then submit it to Health Canada – Canada’s version of the FDA. We hope to have this study fully approved and ready to begin in early 2009.
The budget for this study is $150,000, all of which remains to be raised.