Health Canada has approved the first clinical trials testing the efficacy and safety of two CBD-dominant oils for treating insomnia in people suffering from major depressive disorder (MDD).
On Tuesday, Ontario-based MediPharm Labs Corp. (TSX: LABS) said its research partner McMaster University has received approval to begin recruiting human subjects to test a “very” high-CBD oil called CBD50. A second oil called CBD10:2, with a high-CBD and low-THC concentration, will also be tested.
The placebo-controlled Phase 2 trial is being conducted by a clinical research group led by McMaster University professor Dr. Benicio Frey at St. Joseph’s Healthcare Hamilton research hospital in Ontario.
“This study will create opportunities to show efficacy in our already commercialized cannabis oil while also making progress on our long-term goal to manufacture pharmaceutical drugs containing cannabinoids as an active ingredient,” said MediPharm’s CEO Keith Strachan in a statement.
Company stock rose by 4.55 per cent on Tuesday to $0.34 on the Toronto Stock Exchange.
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According to John Hopkins Medicine, 75 per cent of people suffering from MDD have sleeping problems or insomnia, and McMaster researchers say high-CBD oils could provide relief.
MediPharm’s CBD25 oil is similar to the CBD10:2 product to be used in the trial. Photo via MediPharm Labs
“Many individuals around the world are using cannabinoids to treat their sleep problems without robust clinical evidence from placebo-controlled trials,” Frey says, adding that the new trial could be a step towards evidence-based research for the cannabinoid-based insomnia treatments.
CBD10:2 has the same ratio as MediPharm’s CBD25 oil, which is available on the recreational market, with drops containing around 0.63 milligrams of CBD and 0.03 milligrams of THC. The CBD50 oil has around 1.56 milligrams of CBD and 0.06 milligrams of THC per drop.
On August 16, the research group received a letter authorizing the research, which is the second approval of its kind for a clinical trial partnering with McMaster University.
A different trial lead by a separate group received a approval in June to test MediPharm’s CBD50 oil for a randomized trial studying the effect of CBD on persistent post-surgical pain.
According to Health Canada’s website, another clinical trial for cannabinoids and insomnia has been authorized since May 2018. The placebo-controlled trial is led by Canopy Health Innovations Inc., a research subsidiary of Canopy Growth Corporation (TSX: WEED) (Nasdaq: CGC), testing the efficacy of its CHI-921 oil on people suffering from insomnia.
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