This is a Phase II trial with two goals. First, an open-label randomized study to evaluate the effects of cannabis versus fentanyl in adults with breakthrough cancer pain who are already on opioids. Second, a randomized double-blind placebo-controlled trial to evaluate the effect of cannabis or fentanyl as compared to a placebo group with breakthrough cancer pain.

“Medical cannabis may help reduce the use of drugs like fentanyl for treating breakthrough and chronic pain,” said Dr. Guy Chamberland, CEO of Tetra Bio-Pharma, which is running the trial. “However, unrefuted scientific data on its safety and effectiveness that will satisfy regulators, professional groups and insurers is what’s missing.”

This will be the first trial to compare cannabis and opioids in a head-on fashion. Though it is specific to breakthrough cancer pain, it may provide insight into what the strengths and limitations of cannabis are in other types of pain management.



Another trial is looking at CBD oil for managing chronic non-cancer pain. It is sponsored by Hamilton Health Sciences Corporation and the Michael G. DeGroote Institute for Pain Research and Care at McMaster University in Canada. This is also a Phase II trial that seeks to determine whether CBD alone or a combination of CBD and THC reduces the pain of patients with chronic non-cancer pain. The trial will assess pain reduction and associated symptoms, as well as reductions in the use of other medications.



According to the trial protocol, participants will be randomly selected to receive up to 80mg of CBD in capsules for 12 weeks. The doses are many times greater than the commercial CBD oils, edibles and other products that are available over-the-counter, so this trial should help clarify how much CBD is needed to treat pain.



Research is underway in the United States as well, in particular at places like the UCLA Cannabis Research Initiative and at Washington State University. The results of these and other trials will enable sound clinical decisions for cannabis in pain management. At present, a lack of information hampers clinicians.

This was demonstrated in a recent article in The New England Journal of Medicine that looked at the pros and cons of using medical cannabis to treat a woman with Complex Regional Pain Syndrome. Even the doctor who wrote in favor of cannabis admitted “high-quality evidence is limited” on its effectiveness as a pain reliever, although experiments on animals “provide reassuring support on safety.”

The studies now underway will better inform doctors about such decisions and reduce uncertainty.



Cannabis deserves good science. The changing legal landscape in Canada and the United States is providing research opportunities that will help clarify what cannabis may be useful for and how best to use it.