Tetra Bio-Pharma (TBP.T) received Health Canada’s approval for their amendment of a phase I study involving the safety profile of low and moderate doses of inhaled CBD.
They’re conducting this study with Dr. Jutras-Aswad and the University of Montreal Hospital Research Centre for the safety profile, and specifically looking to determine the cognitive, behavioural and biological effects of CBD in adults who use cannabis occasionally.
‘There is an urgent need to accelerate the research effort to provide accurate information about the effects of cannabinoids and cannabis. This study will be critical to clarify the psychological, cognitive, and biological effects of CBD at doses that are commonly used by consumers. The approval from Health Canada is a major step in achieving these goals,” said Dr Jutras-Aswad.
Remember back in 2018 when all of those companies were getting in regulatory hot water for making claims that weren’t backed-up by solid science? Now some four years later they’re getting around to actually doing the science involved, and that’s more or less what we can expect from the scientific method. It takes time to do it right, but it does get done.
The collaboration has Tetra supplying the synthetic CBD and placebo and gets access to the clinical data from the study in exchange. The data will include safety, pharmacokinetic and pharmacodynamic specifics in humans exposed to Tetra’s CBD product.
Here’s the specifics if you’re a science-type:
The study is a placebo-controlled, triple-blind, crossover randomized controlled trial specifically for the evaluation of the behavioural and biological effects and safety of varying doses of inhaled CBD compared to placebo in 80 healthy adults who occasionally use cannabis. The trial will happen at Centre hospitalier de l’Universite de Montreal (CRCHUM). Age ranges are between 21 and 65. The study is being directed by generale de la sante publique (DGSP) of Quebec’s ministere de la Sante et des Services Sociaux, and in accordance with all of the applicable regulations.
—Joseph Morton
