The first Health Canada-approved clinical trial for medical cannabis in Canadian history launched Tuesday with a public call for participants in Montreal and Halifax.
And one of the study’s two principal investigators says he’s keen to finally generate some solid scientific evidence about the potential of medical cannabis as a meaningful medication to help treat the nearly five million Canadians who suffer from arthritis, as well as other neuropathic conditions.
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“This trial has been years in the making,” said Dr. Mark Ware, a practising pain physician at the McGill University Health Centre, and the executive director of the Canadian Consortium for the Investigation of Cannabinoids.
“It is a huge opportunity for us to finally generate and contribute some data to the discussion on medical cannabis research in Canada.”
The study is being funded by CanniMed, a wholly owned subsidiary of Prairie Plant Systems, a Saskatoon-based plant biotech company that has been growing medical marijuana for Health Canada at two locations in Saskatchewan since 2000.
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Dubbed CAPRI (for CAnnabinoid PRofile Investigation), the year-long study is a randomized, double-blind, placebo-controlled, proof-of-concept crossover clinical trial that will test five varieties of single-dose vaporized cannabis on adults with primary osteoarthritis of the knee.
In the coming days and weeks, a total of 40 men and women age 50-plus who suffer from the condition will be recruited at pain clinics in Montreal and Halifax. The latter clinic is run by CAPRI’s other primary investigator, Dr. Mary Lynch, professor of anesthesiology, pain medicine and perioperative care, psychiatry pharmacology, at Dalhousie University.
According to Dr. Ware, a formal screening process that will include interviews and urine tests will be conducted to weed out unfit candidates. They include current cannabis users and people with pre-existing knee problems or trauma.
“We want so-called naive patients,” said Dr. Ware. ”There is always a giggle factor in all of this but this is a very serious scientific undertaking.”
Study participants, he noted, will come into the clinic once a week and be administered a single vaporized dose of medical marijuana that will be different each time. “It will be conducted in a very strict laboratory environment,” said Dr. Ware.
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The study will end next May, he added, and results detailed in a scientific paper he hopes will be published soon after.
In addition to safety and efficacy parameters, Dr. Ware said the results could provide some unique and practical treatment markers for patients and physicians.
“We’ve standardized the profiles of cannabinoids (and) will be able to look at specific ratios of THC and CBD to help determine whether high levels of both or a combination have the greatest impact on pain and side effects,” Dr. Ware told The Medical Post from downtown Montreal. “That’s never been done before.”
THC, or tetrahydrocannabinol, is the chemical responsible for most of marijuana’s psychological effects. CBD, or cannabidiol, is a sedative compound that provides symptom relief and is known and/or believed to help manage pain, nausea and even seizures.
An orally administered liquid that contains CBD, for example, is an approved orphan drug in the United States (under the brand name Epidiolex) for the treatment for the treatment of Dravet syndrome, a rare and catastrophic form of pediatric epilepsy.
This story originally appeared on our sister site, CanadianHealthcareNetwork.ca.