Cannabinoids for Pain Management and Neuroprotection From Concussion

University of Regina

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Cannabis/Hemp Isolate Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT06204003

NFL-CBD-01 (Other Identifier)

3455 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Dose Escalation

Experimental group

Description:

When participants start the CBD, they will be started on a low dose of CBD, beginning at 5 mg CBD/kg body mass, and then increased by 5 mg/kg every 2-weeks until 30 mg CBD/kg body mass is taken.

Treatment:

Drug: Cannabis/Hemp Isolate Extract