Health Canada approved the amendment of a phase I study conducted in collaboration by leading cannabinoid-derived drug discovery and development company Tetra Bio-Pharma Inc. and Dr. Jutras-Aswad and the University of Montreal Hospital Research Centre.
The study will assess the safety profile of low and moderate doses of inhaled CBD and determine the cognitive, behavioral and biological effects of CBD in adults who occasionally use cannabis. The clinical trial has been authorized by Health Canada, who also recently approved an amendment to the research protocol to increase the dosage of the study drug up to 100 milligrams of CBD to be assessed in the study.
Under the collaboration, Tetra will supply the synthetic cannabidiol investigational drug products and placebo and in exchange will gain access to clinical data collected in the study. The data will include safety, pharmacokinetic and pharmacodynamic in humans exposed to Tetra’s inhaled CBD product.
“We are very pleased to pursue our collaboration with Dr. Jutras-Aswad and the CRCHUM,” said Tetra CEO and Chief Regulatory Officer Guy Chamberland. “Dr. Jutras-Aswad is a reference in cannabinoid research, addiction and mental health. His research meets a public heath need to better understand the impact of cannabinoid use in human health. Together with Dr. Jutras-Aswad and the CRCHUM, one of the largest biomedical and healthcare research centers in Canada, we will advance clinical research and cannabis science in Canada.”
Jutras-Aswad explained that 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,” he said. “The approval from Health Canada is a major step in achieving these goals.”
The study is a placebo-controlled, triple-blind, cross-over randomized controlled trial (RCT) to evaluate the behavioral and biological effects, as well as the safety of varying doses, of inhaled CBD compared to placebo in 80 healthy, adults who occasionally use cannabis.