Healthy
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGCannabis/Hemp Isolate Extract
Formulation: CBD (99%; 0.1% THC isolate)
Sponsors
University of Regina
National Football League (NFL)
My Next Health Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will receive placebo at Day 0. CBD 5 mg/kg will begin Day 15. CBD 10 mg/kg will begin Day 30. CBD 15 mg/kg will begin Day 45. CBD 20 mg/kg will begin Day 60. CBD 25 mg/kg will begin Day75. CBD 30 mg/kg will begin Day 90.
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cerebrovascular and cardiovascular physiology | Every 15 days from Day 0 to Day 104 | Monitor the participant's cerebrovascular and cardiovascular physiology before and after the dosage regimen |
| Incidence of potential harmful side effects | Every 15 days from Day 0 to Day 104 | Follow the participants enrolled in these studies at set intervals to monitor for potential harmful side effects of the high CBD cannabis/hemp extract. This will include bloodwork to assess for possible hematopoietic, renal or hepatic dysfunction, and pharmacokinetic and pharmacodynamic analysis of the dose escalation protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of GABAergic activity | Every 15 days from Day 0 to Day 104 | Assess the inhibitory neurotransmitter δ-aminobutyric acid (GABAergic activity) |
| Change in pain intensity | Every 15 days from Day 0 to Day 104 | Pain Behaviour Measurement system (PBM) scale |
| Cerebral blood flow (transcranial Doppler) | Every 15 days from Day 0 to Day 104 | Assessment of cerebral hemodynamic activity |
| Cerebral oxygenation (near infrared spectroscopy) | Every 15 days from Day 0 to Day 104 | Assessment of cerebral hemodynamic activity |
| Change in QoL | up to day 104 | Assess quality of life (QOL) in study participants by scores on health questionnaires and medication use |
| Incidence of AEs | Through study completion, From Day 0 to Day 104 | Assess adverse events (AEs) in study participants by looking at sleepiness/lethargy, irritability, nausea/vomiting and diarrhea |
Countries
Canada
Contacts
STUDY_DIRECTORPatrick Neary
University of Regina
PRINCIPAL_INVESTIGATORPayam Dehghani,
Saskatchewan Health Authority - Regina Area
Outcome results
None listed