Cannabidiol for Chronic Pain

Overseen By Rosie Smith, M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Staci Gruber, Ph.D.

Disqualifiers: Non-fluent English, IQ < 75, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a high-CBD product (Cannabidiol) can reduce chronic pain symptoms. Participants will take either the CBD product or a placebo for nine weeks to assess improvements in pain, medication use, daily life, and mental sharpness. Individuals with long-term musculoskeletal pain, such as arthritis or injury-related pain, who do not already use CBD, might be suitable candidates. The goal is to determine if CBD can effectively manage chronic pain. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

A previous study found that CBD helped some people with chronic pain relief. About 42% to 66% of participants reported less pain when using CBD. However, some safety concerns exist. Research shows that participants taking high doses of CBD were more likely to drop out, with a rate of about 12.9%, compared to 4.3% for those on low doses and 3.5% for those taking a placebo. This suggests that higher doses might cause more side effects, though specific serious side effects were not detailed in the available studies. Overall, CBD is considered a relatively safe option for managing pain, although more research is needed to fully understand all potential risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic pain?

Unlike the standard treatments for chronic pain, which often include opioids and NSAIDs, cannabidiol (CBD) offers a unique approach by using a non-psychoactive compound derived from cannabis. Researchers are excited about CBD because it targets the body's endocannabinoid system, potentially reducing pain and inflammation without the risk of addiction or severe side effects. Additionally, CBD is administered sublingually, which may offer faster relief compared to traditional oral medications. This combination of benefits makes CBD a promising alternative for managing chronic pain more safely and effectively.

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 chronic pain. Studies have shown mixed results regarding CBD's effectiveness for chronic pain. Some research suggests that CBD can reduce pain by 42% to 66% when used alone or with THC, another cannabis compound. However, other studies found that CBD offered little to no pain relief and was not much different from a placebo. In a large study of 1,750 adults with nerve pain, cannabis-based treatments, including CBD, helped some people experience more than 50% pain relief. Despite these findings, the overall benefit of CBD for chronic pain remains uncertain, and some experts question its effectiveness. ^{1 2 4 6 7}

Who Is on the Research Team?

Staci Gruber, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 21 who speak English fluently and suffer from chronic pain, which could be due to injury, arthritis, fibromyalgia, bursitis, endometriosis or similar conditions. Participants must consent to join the study.

Inclusion Criteria

Subject has provided informed consent

Subject is fluent in English

I am 21 years old or older.

Exclusion Criteria

Estimated IQ < 75

I am not fluent in English.

I have had a head injury or was unconscious for more than 5 minutes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a high-CBD sublingual product or placebo for chronic pain management

9 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 trial tests a high-CBD sublingual product against a placebo over 9 weeks to see its effects on chronic pain symptoms, medication use, overall health status, life quality, thinking abilities and biological markers.

How Is the Trial Designed?

Group I: Cannabidiol Treatment Arm Experimental Treatment 1 Intervention

High-CBD sublingual product administered three times daily for the treatment period.

Group II: Placebo Treatment Arm Placebo Group 1 Intervention

Placebo sublingual product administered three times daily for the treatment period.

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?

Staci Gruber, Ph.D.

Lead Sponsor

Trials

2

Recruited

120+

Etheridge Foundation

Collaborator

Trials

3

Recruited

50+

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 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]

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]

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]

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 a study involving 32 dogs with canine atopic dermatitis, treatment with a mix of CBD and CBDA significantly reduced pruritus (itchiness) scores at 14 and 28 days, indicating its potential effectiveness in alleviating itching associated with the condition.

However, there was no significant improvement in the overall severity of skin lesions as measured by the CADESI-04 score, suggesting that while CBD/CBDA may help with itching, it does not address the skin lesions themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a mixed cannabidiol and cannabidiolic acid based oil on client-owned dogs with atopic dermatitis. Loewinger, M., Wakshlag, JJ., Bowden, D., 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 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9288157/

Efficacy, Safety, and Regulation of Cannabidiol on Chronic Pain in 1750 adult participants with neuropathic pain showed that cannabis-based medicine might help achieve >50% pain relief (primary outcome) ...

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. mdpi.com mdpi.com/2035-8377/17/9/141

Cannabinoids in Chronic Pain: Clinical Outcomes, Adverse ... ... safety concerns. Quantitative data show that discontinuation rates range from 4.3% at low-dose CBD to 12.9% at high-dose CBD, compared with 3.5% on placebo ...

7. 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.