CBD for Chronic Pain

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cannabidiol (CBD), a compound from cannabis, can help reduce chronic pain in Veterans. Participants will receive either CBD or a placebo (a non-active substance) to determine if CBD is more effective at easing pain. Veterans experiencing moderate to severe chronic pain and interested in using cannabis products for pain relief may be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CBD, or cannabidiol, is generally safe for use. Studies have found that CBD, particularly in small amounts, causes few side effects. Most people using CBD for long-term pain reported fewer negative effects, indicating its safety for pain relief.

Some studies have noted that while CBD is mostly safe, caution is advised with store-bought products due to varying quality. However, in controlled settings like clinical trials, CBD is usually a safe choice for many. Overall, CBD appears to be a promising and safe treatment for long-term pain. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for chronic pain, which often include opioids and NSAIDs, cannabidiol (CBD) offers a unique approach. Researchers are excited about CBD because it targets the endocannabinoid system, which plays a key role in regulating pain and inflammation. CBD is derived from cannabis but does not produce the "high" associated with THC, making it a promising option for managing pain without the risk of addiction or psychoactive effects. Additionally, CBD has anti-inflammatory properties, potentially providing relief with fewer side effects compared to traditional pain medications.

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

This trial will compare Cannabidiol (CBD) with a placebo to evaluate its effectiveness in reducing chronic pain. Research has shown that CBD can help reduce chronic pain, with some studies reporting a pain reduction of 42% to 66%. This suggests CBD might help many people manage their pain. However, other studies found that CBD provides little to no relief, performing no better than a placebo (a treatment with no active ingredient). Overall, evidence on CBD's effectiveness for chronic pain is mixed, with some people experiencing benefits and others noticing little change. ^{6 7 8 9 10}

Who Is on the Research Team?

Kevin Boehnke, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40196085/

A Survey on the Use of Cannabidiol (CBD) Isolate, Its ... The key findings of our anonymous online survey are that the use of cannabinoids is positively associated with decreased chronic pain, even at low dosages.

4. 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.

5. 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 ...

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 according ...

7. 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 ...

8. 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.

9. 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.

10. tga.gov.au tga.gov.au/sites/default/files/review-safety-low-dose-cannabidiol.pdf

Safety of low dose cannabidiol The review found that cannabidiol presents a good safety and tolerability profile at the low dose range of under 60mg/day. • The review identified that ...