Canadian MDMA/PTSD Study Still Seeking Permission to Import MDMA; Protocol Amendment Being Submitted
We seem to be making slow, gradual progress in getting our Canadian MDMA/PTSD study started. On June 14, 2010, Principal Investigator Ingrid Pacey, M.D., met in person with Health Canada officials in Ottawa. Wed previously been informed that Health Canada requires that we she officially affiliated with a Canadian research institution (and not just with MAPS). Prior to the June 14th meeting, Dr. Pacey had obtained affiliation with two different research institutes, the University of Victorias (UVic)Center for Addiction Research of BC(CARBC) and the University of British Columbias (UBC)Center for Health Evaluation and Outcome Studies(CHEOS),and had provided this information to Health Canada.
The new information that Dr. Pacey was told on June 14 was that we must obtain written proof of affiliation from the Dean of either of the two Universities with which these research institutions are affiliated. This seems to be a politically motivated requirement since the research institutes have already approved our affiliation. In the U.S. and Switzerland, weve been able to conduct our research without any outside institutional affiliation. In any case, Dr. Pacey and the research organizations will be seeking to obtain approval from the Deans of UBC and UVic. We are pursuing both options simultaneously since approval from either of the Deans is difficult to predict. Wed obtained approval for the actual protocol from both Health Canada and a Canadian IRB by March 2009, so this delay for institutional affiliation has been especially prolonged and frustrating. Fortunately, we have not been deterred from continuing to strive for full approval for what will become the first psychedelic research study to take place in Canada in almost 40 years.
While we wait for institutional affiliation that will satisfy Health Canada, along with permission to import MDMA to start the study, MAPS is submitting an amendment to the original research protocol to Health Canada. We are adding additional long-term (one year) measurements of the effectiveness of MDMA-assisted psychotherapy for PTSD, as well as a new measurement that the FDA now requires for evaluating long-term suicidality in subjects taking any psychiatric drug, known as the Columbia-Suicide Severity Rating Scale (C-SSRS).