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Pubdate: Thu, 10 Oct 2002 Source: National Post (Canada) Copyright: 2002 Southam Inc. Contact: http://www.nationalpost.com/ Details: http://www.mapinc.org/media/286 Author: Tom Arnold, National Post Bookmark: http://www.mapinc.org/mmjcn.htm (Cannabis - Medicinal - Canada) OTTAWA PROBES MARIJUANA'S EFFECT ON PAIN First Clinical Trial to Follow 32 Patients over Eight Weeks The federal government is putting up $840,000 for Canada's first clinical study into whether marijuana use can help ease pain. The Community Research Initiative of Toronto and St. Michael's Hospital in Toronto are to begin evaluating the therapeutic effects of smoked cannabis in HIV/AIDS. In the clinical trial, 32 patients will be closely examined over eight weeks to test the safety of short-term exposure to different strengths of cannabis, and how cannabis interacts with HIV medications. The analysis will also include the effect of smoked marijuana on nausea, pain, mood and neuro-cognitive function. The results of the study will help determine the design of a larger, multi-centre, clinical trial across the country. It is also important because Anne McLellan, the federal Health Minister, has said she will not proceed with medicinal legalization without clinical trials looking at the plant's effectiveness. "There is so little good concrete scientific data about the potential benefits or effects of smoked cannabis in a number of illnesses, including HIV and AIDS," said Kevin Gough, an infectious diseases specialist who will act as the study's principal investigator. "HIV itself, the disease, and the medications we use to treat it, produce a number of side effects, including loss of appetite, nausea, and pain. Other diseases like cancer and multiple sclerosis can also lead to similar symptoms that might benefit from smoked cannabis, but the studies aren't there. "This is the first trial in Canada to be looking at cannabis in any medical context," added Dr. Gough, who is also medical director of HIV services at St. Michael's Hospital in Toronto. For those suffering from HIV or AIDS, loss of appetite and weight loss can be life threatening, said Derek Thaczuk, former chairman of the board of directors of the Community Research Initiative of Toronto, an organization dedicated to research on HIV and AIDS. "There is plenty of anecdotal evidence to suggest that smoking marijuana increases people's appetite and therefore helps them gain weight," he said. "What we're doing with this study is subjecting it to some scientific rigour and trying to get quantitative answers to the question of 'Can smoked cannabis help with this condition and if so, how much?' " The marijuana has been imported from the U.S. government's National Institutes of Drug Abuse. The organization grows its own marijuana on a farm in Mississippi. The Canadian research team purchased 500 grams for the research project. Mr. Thaczuk, who chairs the Toronto research initiative's scientific committee, said work on the study has been carried out for two years with Health Canada, and the scientific and HIV/AIDS communities. The study is based on a method known as a placebo-controlled crossover design. This means all participants will receive marijuana containing four different strengths of tetrahydrocannabinol (THC) at different times, including a placebo. Each patient will smoke the various forms of the drug for a week, monitoring their usage, pain level and weight. They will remain marijuana-free for the next week, but still self-monitoring. Although they will be smoking medicinal pot in their own homes whenever they choose, they will undergo a battery of tests as an in-patient at a clinic once a week. THC is the component of cannabis known to cause the "high" people experience. THC is also believed responsible for the drug's potential medical benefits, such as appetite stimulation. The study is expected to be completed within one year. The federal government has funded another study, one in which researchers at McGill University will research the therapeutic effects of marijuana on neurological pain. The $235,000 project is to get underway this fall. In August, Ms. McLellan prompted applause when she told doctors at a meeting of the Canadian Medical Association in New Brunswick that she was uncomfortable with people smoking pot to relieve pain and that the government would not look at distributing medicinal marijuana before it does clinical drug trials. Ms. McLellan's comments appeared to contradict her predecessor Allan Rock, who had suggested he was looking at easing up on legal access to the drug as medicine. However, she insisted she was not backing away from the government's plan to distribute marijuana for medicinal purposes. Like any other drug, she said, the safety, efficacy and long-term effects of marijuana must be studied before approval. Canadian doctors have led a powerful lobby against prescribing pot as medicine, arguing it has not been tested for safety or efficacy. - --- MAP posted-by: Terry Liittschwager