The National Football League (NFL) is partnering with researchers in order to conduct clinical trials on the safety and efficiency of the marijuana compound cannabidiol (CBD) for treating pain and providing protection against concussions.
“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”, states a notice announcing the study.
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.
The study is being conducted by researchers at the University of Regina, with funding from the NFL and My Next Health Inc.
“This research project will be a Phase I clinical trial to test the safety, efficacy and tolerability of the drug formulation”, states the study’s overview. “Specifically, the investigators will use a dose escalation study with all participants taking a placebo before starting the CBD regimen. This study is designed to investigate anti-inflammatory and neuroprotection of the CBD formulation to determine whether it can be used on a daily basis safely during the periods of intensive exercise (resistance) training during the off-season prior to competition.”
The primary research hypothesis “is that cannabis/hemp-based products with high CBD are safe, well-tolerated and do not cause adverse physiological and psychological dysfunction when administered on a daily basis. Specifically, the investigators will investigate the pharmacokinetic, physiological, and psychological effects of CBD. The investigators hypothesize that the CBD formulations will be non-intoxicating (non-psychotropic), safe, well-tolerated and do not cause adverse physiological or psychological dysfunction.”
More information on this forthcoming study, which is expected to be completed by 2026, can be found by clicking here.
