First Health Canada-Approved Medical Cannabis Trial Targets Osteoarthritis

The first Health Canada-approved clinical trial for medical cannabis has started patient recruitment to determine the pain-relieving characteristics of vaporized cannabis.

The year-long Canadian study, which began patient recruitment June 23, 2015, is seeking participants aged 50 years or older who have primary osteoarthritis, or degenerative joint disease, of the knee. Patients will be considered if they are on a stable medication and treatment regimen, and not currently using cannabinoids.

The study is being funded by CanniMed Ltd., a wholly owned subsidiary of Saskatoon, Saskatchewan-based Prairie Plant Systems Inc. CanniMed is a licensed producer under Canada’s Marihuana for Medical Purposes Regulations, and its pharmaceutical-grade marijuana is produced under Good Manufacturing Practices regulations, the criteria used to manufacture all pharmaceuticals in Canada.

Prairie Plant Systems and CanniMed are teaming up with researchers at Canada’s McGill University Health Centre and Dalhousie Universities to offer the study, “Cannabinoid Profile Investigation of Vaporized Cannabis in Patients with Osteoarthritis of the Knee.” The trial is a randomized, double blind, placebo controlled, proof-of-concept, crossover clinical trial of single dose vaporized cannabis.

The study will seek to understand the analgesic dose-response of six varieties of medical cannabis, consisting of varying concentrations of the two most common active ingredients: delta-9-tetrahydrocannabinol and cannabidiol—with one of those being a placebo. It will also explore the short-term safety of vaporized cannabis as well as look at functional changes and patient preference.

“The idea is to hone in on that specific dosing patients need to help manage their symptoms,” Brent Zettl, president and CEO of Prairie Plant Systems Inc. and CanniMed Ltd, told MJINews, adding that a “stoned response” signals overdose.

Vaporizing is most recommended by doctors, Zettl said, adding that past studies have shown patients feel symptom relief after two minutes of having cannabis administered through vaporizing. Patients will use the Volcano vaporizer, which has been approved as a medical device.

The body’s own pain-regulating system, called the endocannabinoid system, has receptors in nervous system tissue, immune cells, bone and joint tissue, CanniMed explained in a statement. “These receptors respond to the cannabinoids found in medical cannabis, similar to how a key opens a lock,” CanniMed added. “Research has demonstrated the short term efficacy of medical cannabis at reducing pain when used by itself or in combination with other pain-relievers, but comparisons between cannabinoid ratios have not been tested in clinical settings.”

Osteoarthritis is the most common type of arthritis and affects one in 10 Canadian adults, according to The Arthritis Society. “As soon as we get a more disciplined drug delivery system we will have a lot less people in pain,” Zettl said about the need for clinical trials like these. “If you go into [a dispensary] and test those strains you will find the THC/CBD ratios are all over the map—even products being sold under the same name. We are trying to subsidize our endocannabinoid system so it can function properly. The science is coming to bear and new medicines are going to be much more effective than the ones we currently have.”

The trial significantly advances medical cannabis research in Canada, said Dr. Mark Ware, CAPRI trial primary investigator and practicing pain physician at the McGill University Health Centre, and executive director of the Canadian Consortium for the Investigation of Cannabinoids, in a statement. “This research will help to start answering important questions physicians have regarding dosing as well as short term safety and efficacy related to specific ratios of cannabinoids,” Ware said.

Clinical trials like these will help to take the guesswork out of what kind of and how much medical marijuana doctors should prescribe, making cannabis a more viable treatment method for those who need it most.

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