This study was conducted in order to determine the safety and tolerability of escalating doses of three cannabis oil formulations, containing predominantly cannabidiol (CBD), tetrahydrocannabinol (THC), or CBD and THC (1.5:1) vs. placebo in dogs. Twenty healthy Beagle dogs (10 males and 10 females) were used in this randomized, placebo-controlled, blinded, parallel study.
Dogs were randomly assigned to one of five treatment groups (2 males and 2 females per group): CBD-predominant oil, THC-predominant oil, CBD/THC-predominant oil (1.5:1), sunflower oil placebo, medium-chain triglyceride (MCT) oil placebo. Up to 10 escalating doses of the oils were planned for administration via oral gavage, with at least 3 days separating doses. Clinical observations, physical examinations, complete blood counts, clinical chemistry, and plasma cannabinoids were used to assess safety, tolerability, and the occurrence of adverse events which were rated as mild, moderate, or severe/medically significant.
Dose escalation of the CBD-predominant oil formulation was shown to be as safe as placebo and safer than dose escalation of oils containing THC (CBD/THC oil or THC oil). The placebo oils were delivered up to 10 escalating volumes, the CBD oil up to the tenth dose (~62 mg/kg), the THC oil up to the tenth dose ( ~49 mg/kg), and the CBD/THC oil up to the fifth dose (~12 mg/kg CBD + 8 mg/kg THC).
Adverse events were reported in all dogs across the five groups and the majority (94.9%) were mild. Moderate adverse events (4.4% of total) and severe/medically significant adverse events (0.8% of total) manifested as constitutional (lethargy, hypothermia) or neurological (ataxia) symptoms and mainly occurred across the two groups receiving oils containing THC (CBD/THC oil or THC oil).
Overall, dogs tolerated dose escalation of the cannabidiol oil well, experiencing only mild adverse events. The favorable safety profile of 10 escalating doses of a cannabidiol oil containing (~2-62 mg/kg) cannabidiol per dose provides comparative evidence that, at our investigated doses, a CBD-predominant oil formulation was safer and more tolerated in dogs than oil formulations containing higher concentrations of THC.
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