December 2004

McGill University

First-ever safety study of medical cannabis use in Canada launched

Cannabis study

MONTREAL, 8 December 2004 -- A first-of-its-kind study of safety issues surrounding the medical use of cannabis has just been launched. Known as the COMPASS study (Cannabis for the management of pain: assessment of safety study), the research initiative will follow 1400 chronic pain patients, 350 of whom use cannabis as part of their pain management strategy, for a one-year period. Seven participating pain clinics across Canada are now enrolling patients for this study.

"Patients in COMPASS will typically have pain resulting from spinal cord injuries, multiple sclerosis, arthritis or other kinds of hard-to-treat neuropathic or muscle pain," explains Dr. Mark Ware, principal investigator and pain physician at the McGill University Health Centre (MUHC) Pain Centre. "We are not recruiting cancer patients for this study."

"COMPASS participants will be given access to research-grade herbal cannabis and followed for one year," adds Dr. Jean-Paul Collet, also a principal investigator and Professor of Epidemiology at McGill University.

"We'll be looking at a range of safety issues, including adverse events, kidney, liver, heart and lung function and hormone levels," he says. "Patients will also do tests at the start and end of the study, to help determine whether medical use of cannabis affects cognitive function."

Since 1999, Canadian patients have been able to use cannabis for medical reasons, under specific circumstances, with a physician's recommendation and Health Canada authorization. However, until now, the safety of cannabis used for medical purposes has not been scientifically studied.

"Other studies are looking at whether cannabis relieves pain and other symptoms," says Dr. Ware. "These studies are important, but we also need to know how safe cannabis used for medical purposes actually is. The experience of recreational users gives us some information, but we must understand safety issues in patients who are taking multiple medications and who may have diseases like high blood pressure or diabetes which complicate the picture."

The herbal cannabis to be used in the COMPASS study is produced by Prairie Plant Systems Inc under contract to Health Canada. The strain used in this study contains about 12 percent THC (the active ingredient). Government-supplied cannabis will be sent to pharmacies at each site and dispensed to patients there.

"Right now, thousands of Canadians are using cannabis to treat their pain," says Dr. Ware. "We need much more information on the safety issues facing these patients. COMPASS is the first-ever attempt to collect this information over an extended period, under a wide range of conditions and in real-world settings."

Patients wishing to participate in the COMPASS study should call 1-866-302-4636 (toll-free) and leave their names and telephone numbers. A study coordinator will contact prospective patients to assess whether they meet study requirements. All patient information will be held in strict confidence. Further information is available from www.gereq.net/compass.



Sites enrolling patients are the Arthritis Research Center of Canada in Vancouver, the Meadowlark Place Professional Centre in Edmonton, the London Health Sciences Centre, the MUHC and the Centre hospitalier de l'Universit� de Montr�al (CHUM) in Montreal, the Stan Cassidy Centre for Rehabilitation in Fredericton and the QEII Health Sciences Centre in Halifax. This study is financially supported by a $1.8million grant from Health Canada through the Marijuana Open Label Safety Initiative (MOLSI), a grant partnership program with Canadian Institutes of Health Research.

For more information please contact: Ian Popple
Communications Coordinator (research)
MUHC Public Relations and Communications
514-843-1560

Media contacts for other participating centres can be found at www.gereq.net/compass.




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