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

24 Participants Needed

Trial Summary

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.

What data supports the idea that CBD for Chronic Pain is an effective drug?

The available research shows mixed results about the effectiveness of CBD for chronic pain. One systematic review found some benefits of CBD for chronic pain, sleep improvement, and quality of life, suggesting it could be a good alternative to opioids because it doesn't cause intoxication. However, another study found that CBD did not significantly reduce pain compared to a placebo in a controlled trial. More research is needed to confirm its effectiveness and determine the best way to use it. ^{1 2 3 4 5}

What safety data exists for CBD in treating chronic pain?

The safety data for CBD in treating chronic pain is limited but suggests that CBD is generally well-tolerated. A systematic review found that CBD is non-intoxicating and may be a safer alternative to opioids. A placebo-controlled study indicated that CBD has a similar safety profile to placebo, with no significant adverse effects reported. However, the risk of adulteration in freely available CBD products and potential health hazards for pregnant women are noted concerns. More clinical trials are needed to establish comprehensive safety data. ^{2 3 4 6 7}

Is the drug Cannabidiol (CBD) a promising treatment for chronic pain?

Yes, Cannabidiol (CBD) is considered a promising treatment for chronic pain. It is a natural compound that has shown potential in reducing pain and improving quality of life in animal models and some human studies. CBD is well-tolerated and could offer a non-addictive alternative to traditional pain medications. ^{1 2 5 8 9}

What is the purpose of this trial?

This is a study designed to examine the neurochemical mechanisms associated with Cannabidiol (CBD) versus placebo for chronic non-cancer pain.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States 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). [2023]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, and Regulation of Cannabidiol on Chronic Pain: A Systematic Review. [2022]

4. Switzerland 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol (CBD) as a treatment of acute and chronic back pain: A case series and literature review. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol treatment in hand osteoarthritis and psoriatic arthritis: a randomized, double-blind, placebo-controlled trial. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Balanced Approach for Cannabidiol Use in Chronic Pain. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Chronic Pain and Cannabidiol in Animal Models: Behavioral Pharmacology and Future Perspectives. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Cannabidiol bioavailability after nasal and transdermal application: effect of permeation enhancers. [2022]