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HealthyPhase 1NCT06204003

Cannabinoids for Pain Management and Neuroprotection From Concussion

A Phase 1 study testing Cannabis/Hemp Isolate Extract in people with Healthy, run by University of Regina at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Cannabis/Hemp Isolate Extract
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
2 sitesCanada
Study dates
15 Feb 2024to 30 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

2 sites in 1 country.

Canada2 sites

  • University of Regina

    Regina, Saskatchewan, S4S 0A2

  • Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

Other trials in Canada

About this study

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

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:

Read more
  • 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.
Read the 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.
Conditions
Healthy
Being tested
Cannabis/Hemp Isolate Extract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabis/Hemp Isolate ExtractDrug

    Also called Herbal Extract with a high CBD

    Formulation: CBD (99%; 0.1% THC isolate)

Study groups in NCT06204003
Study groupRoleWhat they receive
Dose EscalationExperimentalWhen 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.
Receives: Drug: Cannabis/Hemp Isolate Extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cerebrovascular and cardiovascular physiology

    Monitor the participant's cerebrovascular and cardiovascular physiology before and after the dosage regimen

    Measured: Every 15 days from Day 0 to Day 104

  2. 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

    Measured: Every 15 days from Day 0 to Day 104

Secondary outcomes (6)

  1. Assessment of GABAergic activity

    Assess the inhibitory neurotransmitter δ-aminobutyric acid (GABAergic activity)

    Measured: Every 15 days from Day 0 to Day 104

  2. Change in pain intensity

    Pain Behaviour Measurement system (PBM) scale

    Measured: Every 15 days from Day 0 to Day 104

  3. Cerebral blood flow (transcranial Doppler)

    Assessment of cerebral hemodynamic activity

    Measured: Every 15 days from Day 0 to Day 104

  4. Cerebral oxygenation (near infrared spectroscopy)

    Assessment of cerebral hemodynamic activity

    Measured: Every 15 days from Day 0 to Day 104

  5. Change in QoL

    Assess quality of life (QOL) in study participants by scores on health questionnaires and medication use

    Measured: up to day 104

  6. Incidence of AEs

    Assess adverse events (AEs) in study participants by looking at sleepiness/lethargy, irritability, nausea/vomiting and diarrhea

    Measured: Through study completion, From Day 0 to Day 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2024
  2. Study start15 Feb 2024
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06204003
Sponsor's protocol ID
3455
Other IDs
NFL-CBD-01
Status last verified
Apr 2026
First submitted
24 Jul 2023
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Neary JP, Singh J, Alcorn J, Laprairie RB, Dehghani P, Mang CS, Bjornson BH, Hadjistavropoulos T, Bardutz HA, Bhagaloo L, Walsh Z, Szafron M, Dorsch KD, Thompson ES. Pharmacological and physiological effects of cannabidiol: a dose escalation, placebo washout study protocol. BMC Neurol. 2024 Sep 12;24(1):340. doi: 10.1186/s12883-024-03847-1.

    PubMed 39266961

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cannabis/Hemp Isolate Extract in people with Healthy, run by University of Regina at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cerebrovascular and cardiovascular physiology (time frame: Every 15 days from Day 0 to Day 104). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06204003, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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