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Cannabinoids for Pain Management and Neuroprotection From Concussion
Sponsor: University of Regina
Summary
The goal of this open-label, placebo-controlled, dosage escalation study is to learn about the safety of a Cannabis/Hemp Isolate Extract in normal healthy adults engaged in elite contact sport competition. The main question it aims to answer is: • Are cannabis/hemp-based products with high CBD safe, well-tolerated and without adverse physiological and psychological dysfunction, when administered on a daily basis? Participants will: * be given CBD and a placebo. The placebo will be taken for 2 weeks prior to starting the CBD. Participants will start on a low dose of CBD, beginning at 5 mg CBD/kg body mass, which will be increased by 5 mg/kg every 2-weeks until 30 mg CBD/kg body mass is taken; * have blood samples taken to analyse how much CBD is used in the body and for how long it lasts in the body (pharmacokinetics and pharmacodynamics); * have saliva samples collected for genetic analysis; * undergo testing sessions, which will include psychological and health questionnaires, equipment to record signals from the brain and heart, and safety laboratory tests.
Official title: Naturally Produced Cannabinoids for Pain Management and Neuroprotection From Concussion During Participation in Contact Sports: Dose Escalation
Key Details
Gender
MALE
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2024-02-15
Completion Date
2026-12
Last Updated
2024-07-01
Healthy Volunteers
Yes
Conditions
Interventions
Cannabis/Hemp Isolate Extract
Formulation: CBD (99%; 0.1% THC isolate)
Locations (2)
University of Regina
Regina, Saskatchewan, Canada
Pasqua Hospital
Regina, Saskatchewan, Canada