Tetra Bio-Pharma Inc., a leader in cannabinoid-derived drug discovery and development announced that Health Canada approved the amendment of a phase I study conducted in collaboration with Dr. Jutras-Aswad and the University of Montreal Hospital Research Centre (Centre de recherche du Centre hospitalier de l’Université de Montréal, (CRCHUM). 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 mg 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.
Guy Chamberland, CEO and Chief Regulatory Officer of Tetra, commented, “we are very pleased to pursue our collaboration with Dr. Jutras-Aswad and the CRCHUM. 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 centres in Canada, we will advance clinical research and cannabis science in Canada.”
Dr. Jutras-Aswad commented, ”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.”
About the Clinical Trial
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. The trial will take place at the CRCHUM in Montreal, Quebec. Participants will be healthy adults between the ages of 21 and 65, who use cannabis occasionally. The study is funded by the Direction générale de la santé publique (DGSP) of Quebec’s ministère de la Santé et des Services Sociaux. This clinical study will be conducted in accordance with applicable Health Canada regulations, ICH guidelines on current GCP, and the Declaration of Helsinki.
About Dr. Didier Jutras-Aswad
Dr. Jutras-Aswad is the Chief of Staff of the Department of Psychiatry at the Centre hospitalier de l’Université de Montréal (CHUM), where he practices as an Addiction Psychiatrist. He is an associate professor at the Université de Montréal (UdeM) and President of UdeM’s Centre d’expertise et de collaboration en troubles concomitants. As the principal scientist at the CHUM research centre where his work focuses on cannabis, addiction, and comorbid conditions, particularly mental health disorders, he is regularly consulted by government bodies for questions pertaining to cannabis, substance use, and mental health. He leads clinical trials at the local and national levels, focusing on the development and evaluation of the best interventions and models of care for these conditions. He also developed a dynamic clinical research program to study the effects of cannabinoids administration in humans.
About the CRCHUM
The University of Montreal Hospital Research Centre (CRCHUM) is one of North America’s leading hospital research centres. It strives to improve adult health through a research continuum covering such disciplines as the fundamental sciences, clinical research, and public health. Over 2,300 people work at the CRCHUM, including more than 500 researchers and more than 520 graduate students. For more information: www.chumontreal.qc.ca/crchum and @CRCHUM
About Tetra Bio-Pharma
Tetra Bio-Pharma is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies. For more information: www.tetrabiopharma.com
