cannabinoids for pain management and neuroprotection from concussion

Conditions: Healthy

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.

this research project will be a phase i clinical trial to test the safety, efficacy and tolerability of the drug formulation. 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. secondary research hypotheses for this clinical trial: 1. pharmacokinetic data will provide the investigators with the 'optimal' formulation for daily administration for neuroprotection from concussion 2. plasma levels of cbd and/or its active metabolites will correlate with cerebrovascular, neurophysiology and cardiovascular physiology outcome variables. 3. saliva levels of cbd and/or its active metabolites will correlate with plasma samples.

Eligibility criteria:
inclusion criteria: * healthy male adults between 18-35 years of age that compete in contact sport athletics * no known cerebrovascular or cardiovascular complications * not habitual recreational users of cannabis (i.e., \<1 day/week) or tobacco users * agree not to consume any other cannabis or tobacco products while enrolled in the study * agree to list any prescription medications being taken * ability to maintain commitment to all proposed biopsychological and health questionnaires, and neuro-physiological, physiological, perceptual-cognitive, and functional motor skills laboratory tests exclusion criteria: * female * requirement to travel to the usa during study period; usa laws do not permit cross border with cannabis products * use of cannabis-based therapy within 2 months (participants who have previously used a cannabis based therapy may be included if they have a 2 month period without use of cannabis based therapy prior to enrolment in the study) * any level of cannabis in blood samples when sampled at the commencement of the study * medically supervised for anxiety, depression, or other neurological conditions * initiation or dosage change of oral or injected steroids within past 3 months * allergy or known intolerance to any of the compounds within the study preparation * inability to attend assessments on a regular basis at the pre-determined times, or failure to take drug on a daily basis * clinically significant cardiac, renal or hepatic disease (as assessed by the site investigator) * concussion