CBD for Chronic Pain

Recruiting in Ann Arbor (>99 mi)

Overseen By Vivian Kurtz, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kevin Boehnke

Must not be taking: Valproate, Clobazam

Disqualifiers: Pregnancy, Suicidal ideation, Neurological disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

468 Participants Needed

Trial Summary

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

The trial does not specify if you need to stop taking your current medications, but you must not increase your use of THC or other cannabis products during the study. If you are using valproate or clobazam, you cannot participate in the trial.

What data supports the effectiveness of the drug CBD for chronic pain?

Some studies suggest that CBD may help with chronic pain and improve sleep and quality of life, making it a potential alternative to opioids. However, more research is needed to confirm its effectiveness and safety. ^{1 2 3 4 5}

Is CBD safe for humans?

Research suggests that CBD is generally safe for humans, with studies showing it is non-intoxicating in its pure form and has a good safety profile. However, there is a risk of adulteration in freely available CBD products, and its use during pregnancy may pose health risks. ^{2 3 4 6 7}

How does the drug CBD differ from other treatments for chronic pain?

CBD is unique because it is a nonpsychoactive compound that offers a potential nonaddictive, nonopioid option for chronic pain relief, with promising results in animal models and some human studies. It can be administered through various routes, including oral, transdermal, and intranasal, which may provide flexible and patient-centered pain management. ^{1 2 5 8 9}

What is the purpose of this trial?

This research is studying the effects of cannabidiol (CBD), an active component from cannabis (a.k.a. marijuana), on Veterans' chronic pain. The purpose of this study is to better understand if CBD can improve pain symptoms in Veterans with chronic pain. Eligible participants will be randomly assigned to receive either placebo medication (not active) or CBD during the study period. The study hypotheses: - CBD would improve overall pain symptoms compared to placebo

Research Team

Kevin Boehnke, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for Veterans experiencing chronic pain. Participants will be randomly assigned to receive either a placebo or CBD, which is an active component of cannabis thought to help with pain.

Inclusion Criteria

Individuals of reproductive potential must agree to use acceptable birth control per protocol

Willingness to fill out daily diary via smartphone to assess symptom status, study drug use, and other cannabis use

Armed Services Veteran

Exclusion Criteria

Individuals with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, and seizures

Medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study (e.g., psychosis, suicidal ideation; note that stable anxiety and depression are not exclusions)

Risk for imminent harm - Suicidal ideation or wish to die as assessed per protocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or CBD to assess effects on chronic pain

4 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cannabidiol
• Placebo

Trial Overview The study aims to determine if CBD can provide better relief from chronic pain symptoms in Veterans compared to a placebo (a substance with no therapeutic effect).

Participant Groups

Group I: Cannabidiol Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

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?

Kevin Boehnke

Lead Sponsor

Trials

2

Recruited

480+

Michigan, State of, Licensing and Regulatory Affairs

Collaborator

Trials

3

Recruited

960+

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]

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 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]

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. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

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]