Cannabinoids for Pain Management and Neuroprotection

Recruiting at 1 trial location

Overseen By Jyotpal Singh

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: University of Regina

Must not be taking: Steroids

Disqualifiers: Female, Neurological conditions, Cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of cannabis/hemp-based products, specifically those with high CBD content, for pain management and neuroprotection. The research aims to determine if these products are safe and well-tolerated when used daily by healthy adults in elite contact sports. Participants will begin with a low dose of CBD, gradually increasing it to study its effects and how the body processes it. Healthy male athletes who do not frequently use cannabis or tobacco and are committed to various health and psychological assessments may be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you must list any prescription medications you are taking. You cannot use cannabis-based therapy within 2 months before the study or during the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that CBD, a compound found in cannabis and hemp, is generally safe to use. Some studies have found that people using CBD for pain relief usually tolerate it well. However, side effects such as trouble sleeping and interactions with other medications can occur.

A review on CBD's safety suggests that while many people benefit from it, limited information exists on the safety of over-the-counter CBD products. This indicates that while CBD has potential, more research is needed to understand all possible effects.

Overall, CBD is considered safe, but like any treatment, it affects each person differently. Always consult healthcare professionals before starting a new treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Cannabis/Hemp Isolate Extract is unique because it utilizes cannabinoids for both pain management and neuroprotection, offering a natural alternative to traditional pain medications like opioids or NSAIDs. Unlike conventional treatments that primarily target symptoms, cannabinoids may interact with the body's endocannabinoid system, potentially addressing underlying causes of pain and providing neuroprotective benefits. Researchers are excited because this extract could offer a safer option with fewer side effects and a lower risk of addiction compared to current pain management strategies.

What evidence suggests that this Cannabis/Hemp Isolate Extract might be an effective treatment for pain management and neuroprotection?

Research has shown that CBD, a compound found in cannabis, may help manage various types of pain. Studies have found that using CBD alone or with THC, another compound in cannabis, can reduce pain by 42% to 66%. Cannabinoids like CBD are somewhat effective for conditions such as nerve pain, fibromyalgia, and some cancer-related pain. While more research is needed, CBD is considered a relatively safe option for managing pain and anxiety. However, some studies suggest it might have limited effects for certain types of long-term pain. Participants in this trial will start with a low dose of CBD, gradually increasing it to evaluate its effectiveness and safety in pain management and neuroprotection. ^{6 7 8 9 10}

Who Is on the Research Team?

Patrick Neary

Principal Investigator

University of Regina

Payam Dehghani,

Principal Investigator

Saskatchewan Health Authority - Regina Area

Are You a Good Fit for This Trial?

This trial is for healthy adults who play elite contact sports. They should be interested in exploring the effects of a Cannabis/Hemp Isolate Extract with high CBD content on pain management and neuroprotection from concussion. Participants must not have any health conditions that exclude them from safely taking part.

Inclusion Criteria

I have no history of stroke or heart issues.

Not habitual recreational users of cannabis (i.e., <1 day/week) or tobacco users

I am a healthy male aged 18-35 and compete in contact sports.

Exclusion Criteria

I am female.

I can attend regular assessments and take daily medication.

Allergy or known intolerance to any of the compounds within the study preparation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo

Participants take a placebo for 2 weeks prior to starting the CBD regimen

2 weeks

1 visit (in-person)

Dose Escalation Treatment

Participants start on a low dose of CBD, beginning at 5 mg CBD/kg body mass, increased by 5 mg/kg every 2 weeks until 30 mg CBD/kg body mass is taken

12 weeks

7 visits (in-person) every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabis/Hemp Isolate Extract

Trial Overview The study tests the safety of escalating doses of Cannabis/Hemp Isolate Extract, starting at 5 mg CBD per kg body mass up to 30 mg/kg. It's an open-label, placebo-controlled study where participants first take a placebo then switch to CBD while undergoing various tests and sample collections.

How Is the Trial Designed?

Group I: Dose Escalation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

My Next Health Inc.

Collaborator

Trials

1

Recruited

40+

National Football League (NFL)

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

A new liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method was successfully developed to accurately identify and quantify THC and CBD in olive oil, showing linearity and low imprecision over a range of concentrations.

The extraction efficiency of THC and CBD from olive oil can be significantly improved by optimizing the extraction temperature, with a 2°C increase leading to a notable rise in extraction percentages for both cannabinoids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Use of Δ9-THC and Cannabidiol: Evaluation of a New Extraction Procedure for the Preparation of Cannabis-based Olive Oil. Morini, L., Porro, G., Liso, M., et al.[2018]

In a mouse model of chemotherapy-induced neuropathic pain, both CBD and THC were effective in reducing mechanical sensitivity, with low doses of each showing a synergistic effect when combined.

CBD demonstrated the ability to alleviate pain from oxaliplatin-induced neuropathy, while THC was effective against vincristine-induced pain, suggesting that combining these cannabinoids could enhance treatment options for chemotherapy-related nerve pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single and combined effects of &#916;9 -tetrahydrocannabinol and cannabidiol in a mouse model of chemotherapy-induced neuropathic pain. King, KM., Myers, AM., Soroka-Monzo, AJ., et al.[2021]

This study investigates the effects of cannabis-based medicine (CBM) on spasticity and neuropathic pain in patients with multiple sclerosis and spinal cord injury, using a double-blind, multicenter design with various cannabinoid formulations (THC, CBD, or a combination) compared to a placebo.

The research aims to provide valuable insights into the efficacy and side effects of these cannabinoids, as well as their pharmacodynamics and pharmacokinetics, which are currently not well understood in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Cannabis-Based Medicine on Neuropathic Pain and Spasticity in Patients with Multiple Sclerosis and Spinal Cord Injury: Study Protocol of a National Multicenter Double-Blinded, Placebo-Controlled Trial. Hansen, JS., Hansen, RM., Petersen, T., et al.[2021]

A systematic review of 4186 studies on cannabidiol (CBD) revealed that most research focuses on neurological outcomes, with significant adverse events reported in this area, highlighting the need for careful assessment of CBD's safety.

There is a notable gap in research regarding the reproductive and developmental toxicity of CBD, suggesting that future studies should prioritize these areas to establish safe intake levels for consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Safety Data: A Systematic Mapping Study. Henderson, RG., Franke, KS., Payne, LE., et al.[2023]

In a mouse model of neuropathic pain, the combination of low-dose THC and CBD significantly enhanced pain relief, showing a 200-fold increase in potency compared to THC alone, without increasing side effects.

While higher doses of THC and CBD did provide greater pain relief, they also led to side effects similar to those caused by THC alone, indicating that lower doses may be more beneficial for managing pain with fewer adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis constituent synergy in a mouse neuropathic pain model. Casey, SL., Atwal, N., Vaughan, CW.[2021]

Nearly 50% of CBD users experienced adverse drug events (ADEs), with common issues including elevated liver enzymes, sedation, and sleep disturbances, indicating a significant safety concern.

CBD has a high potential for drug-drug interactions (DDIs) due to its effects on drug metabolism, particularly with enzymes like CYP3A4 and CYP2C19, suggesting that careful monitoring and dose adjustments may be necessary for patients on multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. Brown, JD., Winterstein, AG.[2020]

In a mouse model of neuropathic pain, both THC and CBD were effective in reducing pain when administered orally, but THC also caused side effects at similar doses, indicating a limited therapeutic window.

The combination of THC and CBD did not enhance pain relief compared to THC alone when taken orally, but it did increase the risk of side effects, suggesting that CBD may offer a safer alternative for treating neuropathic pain despite its lower efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral efficacy of Δ(9)-tetrahydrocannabinol and cannabidiol in a mouse neuropathic pain model. Mitchell, VA., Harley, J., Casey, SL., et al.[2021]

Cannabidiolic acid (CBDA) demonstrated significant anti-hyperalgesia and anti-inflammatory effects in a rat model when administered before inflammation, indicating its potential as a more potent alternative to cannabidiol (CBD).

The study found that combining low doses of CBDA and THC, which were ineffective alone, resulted in enhanced anti-hyperalgesia and reduced inflammation, suggesting a synergistic effect between these compounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cannabidiolic acid and &#8710;9-tetrahydrocannabinol on carrageenan-induced hyperalgesia and edema in a rodent model of inflammatory pain. Rock, EM., Limebeer, CL., Parker, LA.[2018]

In a phase III study involving 339 multiple sclerosis patients with central neuropathic pain, the THC/CBD oromucosal spray (Sativex) did not meet the primary endpoint of responder analysis at week 14, showing only a slight difference in response rates compared to placebo (50% vs. 45%).

However, during the randomized-withdrawal phase, the THC/CBD spray significantly delayed treatment failure, with only 24% of patients on the spray failing treatment compared to 57% on placebo, indicating potential long-term benefits of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis. Langford, RM., Mares, J., Novotna, A., et al.[2022]

Pre-clinical studies suggest that cannabidiol (CBD) has neuroprotective effects and may benefit patients with neurodegenerative diseases like Alzheimer's, Parkinson's, and multiple sclerosis, but more robust clinical trials are needed to confirm these findings.

Recent clinical studies indicate that CBD may be effective in treating refractory epilepsy in children and young adults, showing promise as an alternative for patients who do not respond to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological Aspects of Medical Use of Cannabidiol. Mannucci, C., Navarra, M., Calapai, F., et al.[2022]

Targeted spinal delivery of THC and CBD significantly reduces neuropathic pain (allodynia) in a mouse model, with a 1:1 combination showing enhanced effectiveness compared to each compound alone.

Importantly, this method of delivery does not produce the typical side effects associated with THC, suggesting that intrathecal administration could be a safe and effective treatment option for nerve injury-induced pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrathecal Actions of the Cannabis Constituents Δ(9)-Tetrahydrocannabinol and Cannabidiol in a Mouse Neuropathic Pain Model. Casey, SL., Mitchell, VA., Sokolaj, EE., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37953193/

Effectiveness of Cannabidiol to Manage Chronic Pain The majority of the studies indicated pain reduction ranging from 42% - 66% with CBD alone and CBD with Tetrahydrocannabinol.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1524904223001935

Effectiveness of Cannabidiol to Manage Chronic Pain The majority of the studies indicated pain reduction ranging from 42% - 66% with CBD alone and CBD with Tetrahydrocannabinol.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11940634/

Cannabinoids in Chronic Pain Management: A Review of the ... Evidence suggests that cannabinoids provide moderate efficacy in managing neuropathic pain, fibromyalgia, cancer-related pain, and multiple sclerosis-related ...

4. health.harvard.edu health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-201808242496

Cannabidiol (CBD): What we know and what we don't We need more research, but CBD is proving to be a helpful, relatively nontoxic option for managing anxiety, insomnia, and chronic pain.

5. aafp.org aafp.org/pubs/afp/afp-community-blog/entry/cbd-effectiveness-in-treating-chronic-pain-remains-questionable.html

CBD Effectiveness in Treating Chronic Pain Remains ... Many patients use CBD products hoping for relief from chronic pain, but a recently published study shows only minimal, if any, benefit for this indication.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9288157/

Efficacy, Safety, and Regulation of Cannabidiol on Chronic Pain We conducted a systematic review to determine the efficacy and safety of cannabidiol (CBD) for chronic pain. The systematic review is ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11393281/

Clinical Benefits and Safety of Medical Cannabis Products Data from Canada suggests that in addition to pain relief, use of CBD-predominant products in patients with cancer is also associated with improved ESAS-r ...

8. library.samhsa.gov library.samhsa.gov/sites/default/files/pep22-06-04-003.pdf

Cannabidiol (CBD) – Potential Harms, Side Effects, and ... Many concerns have been raised about CBD use, particularly with regard to over-the-counter. CBD products, as there are limited data on their safety and ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2667276624001215

Effectiveness and safety of cannabis-based products for ... Data suggest that medical cannabis is a safe and effective treatment for fibromyalgia pain; however, several limitations regarding dosage, length of treatment ...

10. withpower.com withpower.com/trial/cannabinoids-for-pain-management-and-neuroprotection-bdf1f

Cannabinoids for Pain Management and Neuroprotection Cannabinoids such as CBD and THC have been studied for safety, showing that CBD can cause side effects like sleep disturbances and potential drug interactions, ...