CBD for Chronic Pain

Overseen By Matt Hodgkinson, B.S.,RN

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Utah

Must not be taking: Opioids

Disqualifiers: Neurological illness, Substance abuse, Diabetes, Major mental illness, others

Compensation: Varies

Number of Visits: 7

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Cannabidiol (CBD), a compound from the cannabis plant, might alleviate chronic non-cancer pain. Participants will take either CBD or a placebo (a pill with no active ingredient) for five days, with pain levels assessed before and after each dose. The study aims to understand the brain's response to CBD for pain relief. Individuals with ongoing musculoskeletal or joint pain for at least three months who live near Salt Lake City may be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding CBD's effects in people, offering participants a chance to be among the first to explore its potential benefits for pain relief.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have used opioid medications in the past 30 days.

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

Research has shown that cannabidiol (CBD) might be safe for treating chronic pain, though safety information is still being collected. Some studies found that taking up to 25 mg of CBD per kilogram of body weight daily can increase liver enzymes in some individuals, indicating potential liver issues. However, this side effect is uncommon and usually occurs with higher doses.

Smaller studies suggest that CBD is generally well-tolerated, with most people not experiencing serious side effects. While larger studies are needed to fully understand its safety, most current research indicates that CBD is generally safe for short-term use in managing chronic pain. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Cannabidiol (CBD) for chronic pain because it offers a natural alternative to traditional pain medications like opioids and nonsteroidal anti-inflammatory drugs (NSAIDs). Unlike these standard treatments, CBD is derived from the cannabis plant and is thought to interact with the body's endocannabinoid system, which may help modulate pain without the high risk of addiction. Furthermore, CBD is administered orally, making it a non-invasive option that could provide pain relief with fewer side effects. This potential for effective pain management with a lower risk of dependence or adverse reactions is what makes CBD a promising candidate in the ongoing search for safer chronic pain treatments.

What evidence suggests that Cannabidiol might be an effective treatment for chronic pain?

This trial will compare the effects of Cannabidiol (CBD) with a placebo for managing chronic pain. Research has shown mixed results for CBD in treating chronic pain. Some studies suggest that CBD can reduce pain by 42% to 66%, especially when combined with tetrahydrocannabinol (THC), another compound in cannabis. However, other studies find little to no pain relief with CBD alone, showing no significant difference compared to a placebo. Specifically, one study on arthritis pain found that CBD slightly reduced pain levels. Overall, while some people report benefits, the evidence for CBD's effectiveness in managing chronic pain remains unclear. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-50 who have been experiencing chronic musculoskeletal and joint pain for at least three months. Participants need to live within a 60-mile radius of Salt Lake City, Utah.

Inclusion Criteria

Participants must live within a 60 mile radius of Salt Lake City, Utah to be eligible

I have had joint or muscle pain for 3 months or more.

Exclusion Criteria

Use of opioid medications in the past 30 days

History of seizures or head trauma at PI discretion

Participants may be excluded if the PI feels they do not meet safety criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either Cannabidiol (CBD) or placebo once a day for five days with pain ratings taken before and after each dose

5 days

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol
• Placebo

Trial Overview The study is testing the effects of Cannabidiol (CBD), a compound found in cannabis plants, against a placebo to understand how CBD might alleviate chronic non-cancer pain.

How Is the Trial Designed?

Group I: Cannabidiol Active Control 1 Intervention

Drug: Cannabidiol An oral dose of Cannabidiol (CBD) will be given once a day for five day with pain ratings taken before and after each dose every day. Other Names: CBD

Group II: Placebo Placebo Group 1 Intervention

Drug: Placebos An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day. Other Names: placebo

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

In a study involving 20 healthy volunteers, an 800-mg oral dose of cannabidiol (CBD) did not significantly reduce pain intensity or affect hyperalgesia and allodynia compared to a placebo, suggesting limited efficacy in acute pain management.

The study highlights the need for further research on different dosages and administration methods for CBD, as well as its potential role in combination with other treatments, before concluding its effectiveness for acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain response to cannabidiol in induced acute nociceptive pain, allodynia, and hyperalgesia by using a model mimicking acute pain in healthy adults in a randomized trial (CANAB I). Schneider, T., Zurbriggen, L., Dieterle, M., et al.[2023]

In a randomized, double-blind, placebo-controlled trial involving 136 patients with hand osteoarthritis or psoriatic arthritis, cannabidiol (CBD) did not show a significant reduction in pain intensity compared to placebo after 12 weeks of treatment.

The study found no meaningful effects of CBD on secondary outcomes such as sleep quality, anxiety, or depression, indicating that CBD may not be an effective add-on therapy for pain management in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol treatment in hand osteoarthritis and psoriatic arthritis: a randomized, double-blind, placebo-controlled trial. Vela, J., Dreyer, L., Petersen, KK., et al.[2022]

In two case reports, patients experienced significant pain relief from a lumbar compression fracture and thoracic discomfort after using a transdermal CBD cream, suggesting its potential effectiveness for managing pain.

The CBD cream used in the cases demonstrated antisnociceptive and anti-inflammatory properties, indicating that hemp-derived CBD could be a valuable option for treating both acute and chronic pain, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol (CBD) as a treatment of acute and chronic back pain: A case series and literature review. Eskander, JP., Spall, J., Spall, A., et al.[2020]

Chronic pain affects about 8% of the population and significantly impacts quality of life, but effective and safe treatment options are limited; CBD has emerged as a promising alternative for pain management.

CBD is well-tolerated and has demonstrated analgesic effects in various animal models, reducing pain sensitivity and hyperalgesia, suggesting it could be a valuable treatment for chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Pain and Cannabidiol in Animal Models: Behavioral Pharmacology and Future Perspectives. Silva-Cardoso, GK., Leite-Panissi, CRA.[2023]

A systematic review of 12 studies involving cannabidiol (CBD) suggests it may be an effective alternative for managing chronic pain, as it is non-intoxicating and does not produce the psychoactive effects associated with THC.

While some studies indicate benefits of CBD for chronic pain, sleep improvement, and quality of life, more clinical trials are needed to establish its efficacy and safety definitively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, and Regulation of Cannabidiol on Chronic Pain: A Systematic Review. Villanueva, MRB., Joshaghani, N., Villa, N., et al.[2022]

In a study of 28 patients with chronic neck or back pain, a combination of cannabidiol (CBD) and Δ9-THC was found to be well tolerated, with most side effects being mild, such as nausea and fatigue.

Patients experienced significant reductions in pain scores with higher doses (1.0 mL and 1.5 mL twice daily), achieving reductions of 28.8% and 34.1% respectively, indicating the efficacy of this treatment for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and Efficacy of a 10:25 Preparation of Δ9-Tetrahydrocannabinol and Cannabidiol for Treatment of Chronic Back or Neck Pain: A Multiple-Dose Escalation Study. Glare, P., Chye, R., Bloch, M., et al.[2023]

Cannabidiol (CBD) shows promise as a treatment for chronic pain and certain forms of epilepsy, with evidence suggesting it can improve quality of life for some patients.

Despite its potential benefits, CBD use carries risks, including the possibility of harmful adulterants in freely available products and potential health hazards for pregnant women and their developing babies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Balanced Approach for Cannabidiol Use in Chronic Pain. Argueta, DA., Ventura, CM., Kiven, S., et al.[2021]

In a study involving 17 healthy noncannabis users, cannabidiol (CBD) did not consistently improve pain threshold or tolerance in a cold pressor test, and in some cases, it even increased pain ratings compared to placebo.

While CBD was found to be safe and well tolerated, with minor decreases in blood pressure, it showed only modest effects on mood and potential abuse liability, suggesting that its analgesic effects may not be reliable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A placebo-controlled investigation of the analgesic effects, abuse liability, safety and tolerability of a range of oral cannabidiol doses in healthy humans. Arout, CA., Haney, M., Herrmann, ES., et al.[2022]

Cannabidiol (CBD) can be effectively delivered through both intranasal and transdermal routes, with intranasal delivery achieving absorption within 10 minutes and a bioavailability of 34-46%.

Transdermal delivery of CBD resulted in a significant steady-state plasma concentration for chronic pain relief, which increased 3.7-fold when using permeation enhancers, indicating its potential as a nonaddictive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol bioavailability after nasal and transdermal application: effect of permeation enhancers. Paudel, KS., Hammell, DC., Agu, RU., 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. 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.

4. jpain.org jpain.org/article/S1526-5900(23)00582-5/fulltext

Cannabidiol (CBD) Products for Pain: Ineffective ... Ten of these 11 trials showed that CBD produced little or no pain relief, with no statistical or clinically significant difference between CBD ...

5. cureus.com cureus.com/articles/343272-a-survey-on-the-use-of-cannabidiol-cbd-isolate-its-perceived-benefits-and-associated-side-effects-among-subjects-with-chronic-pain

A Survey on the Use of Cannabidiol (CBD) Isolate, Its ... In a recent study on the effect of CBD as a treatment for pain in arthritis, an absolute reduction of 2.6 ± 2.1 in pain was reported by the ...

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. fda.gov fda.gov/drugs/regulatory-science-action/cder-investigators-address-safety-cbd-randomized-trial

CDER Investigators Address the Safety of CBD in a ... At labeled doses up to 25 mg/kg/day, an increased risk of liver enzyme elevation was observed., Liver enzyme elevations typically occurred after ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04193631

Low Dose of Cannabidiol (CBD) to Treat Mild to Moderate ... The purpose of the study is to evaluate whether Pure Green tablets is a better pain reliever for the treatment of mild to moderate musculoskeletal pain.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1524904223001935?utm_source=bkreader&utm_campaign=bkreader%3A%20outbound&utm_medium=referral

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.