Cannabinoids for Pain Management and Neuroprotection From Concussion

Healthy Clinical Trial

Official title:

Naturally Produced Cannabinoids for Pain Management and Neuroprotection From Concussion During Participation in Contact Sports: Dose Escalation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06204003
• Other study ID #: 3455
• Secondary ID: NFL-CBD-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 2024
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: University of Regina
• Contact: Patrick Neary
• Phone: 306-585-4844
• Email: Patrick.neary[@]uregina.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Cannabis/Hemp Isolate Extract
Formulation: CBD (99%; 0.1% THC isolate)

Locations

Country	Name	City	State
Canada	Pasqua Hospital	Regina	Saskatchewan

Sponsors (3)

Lead Sponsor	Collaborator
University of Regina	My Next Health Inc., National Football League (NFL)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cerebrovascular and cardiovascular physiology	Monitor the participant's cerebrovascular and cardiovascular physiology before and after the dosage regimen	Every 15 days from Day 0 to Day 104
Primary	Incidence of potential harmful side effects	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	Every 15 days from Day 0 to Day 104
Secondary	Assessment of GABAergic activity	Assess the inhibitory neurotransmitter d-aminobutyric acid (GABAergic activity)	Every 15 days from Day 0 to Day 104
Secondary	Change in pain intensity	Pain Behaviour Measurement system (PBM) scale	Every 15 days from Day 0 to Day 104
Secondary	Cerebral blood flow (transcranial Doppler)	Assessment of cerebral hemodynamic activity	Every 15 days from Day 0 to Day 104
Secondary	Cerebral oxygenation (near infrared spectroscopy)	Assessment of cerebral hemodynamic activity	Every 15 days from Day 0 to Day 104
Secondary	Change in QoL	Assess quality of life (QOL) in study participants by scores on health questionnaires and medication use	up to day 104
Secondary	Incidence of AEs	Assess adverse events (AEs) in study participants by looking at sleepiness/lethargy, irritability, nausea/vomiting and diarrhea	Through study completion, From Day 0 to Day 104