CBD for Chronic Low Back Pain

(CBD Trial)

Overseen By Jodi M Gilman, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Immunosuppressants, CNS depressants, Opioids, others

Disqualifiers: Neurological illness, Major psychiatric illness, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will investigate whether cannabidiol (CBD), the primary centrally and peripherally active non-intoxicating compound in the cannabis plant, exerts anti-neuroinflammatory effects in patients with chronic low back pain (cLBP) with or without mild-to-moderate depression.

Will I have to stop taking my current medications?

The trial requires that you stop using cannabis products and certain medications like valproate and clobazam before starting. Some medications will be discussed with a doctor to ensure safety, and any significant changes in your current pain treatment are not allowed during the study.

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

Research suggests that CBD, a component of cannabis, may help relieve pain in conditions like lumbar compression fractures and thoracic discomfort. Additionally, studies have shown that CBD combined with THC (another cannabis component) can be effective for chronic back or neck pain. ^{1 2 3 4 5}

Is CBD safe for humans?

Research on CBD's safety shows it is generally well-tolerated, but some studies report potential adverse effects, especially related to neurological and reproductive health. More research is needed to fully understand its safety profile. ^{1 2 3 4 6}

How is the drug CBD unique for treating chronic low back pain?

CBD is unique for treating chronic low back pain because it offers a potential alternative to traditional painkillers, which often have serious side effects. Unlike many existing treatments, CBD works by modulating serotonin levels and interacting with specific receptors in the body, which may help reduce pain and anxiety without the typical side effects of other medications. ^{1 2 3 5 7}

Eligibility Criteria

This trial is for English-speaking adults aged 18-75 with chronic low back pain lasting at least 6 months, experiencing significant daily pain. Participants must be on stable pain treatment and not using high opioid doses, recreational drugs, or have certain medical conditions like major cardiac events in the past decade.

Inclusion Criteria

My worst daily pain is at least a 4 on a scale of 0-10, and it happens most days of the week.

My genetic test shows I have a specific marker (Ala147Thr) for a study.

I have had chronic low back pain for at least 6 months.

Exclusion Criteria

I have an infection that may be affecting my brain or spinal cord.

Current or past history of major psychiatric illness

I use opioids equal to or more than 30 mg of morphine a month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cannabidiol (CBD) or placebo for 4 weeks, with dosage titration from 2.5 mg/kg to 10 mg/kg twice daily

4 weeks

Weekly visits for dosage titration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cannabidiol

Trial Overview The study tests if CBD can reduce brain inflammation in patients with chronic low back pain, with or without mild-to-moderate depression. It compares the effects of CBD against a placebo to see if it helps manage their condition.

Participant Groups

Group I: Cannabidiol (CBD) Experimental Treatment 1 Intervention

The recommended starting dosage is 2.5mg/kg taken twice daily. The titration schedule recommended in the EPIDIOLEX label will be followed, with 2.5 mg/kg twice daily in week 1, 5 mg/kg twice daily in week 2, 7.5 mg/kg twice daily in week 3, and 10 mg/kg twice daily in week 4 with the second PET scan conducted after one week at the maximum labeled dose. Any participant not tolerating a given dose can either go back down to the next lowest dose or delay uptitration at any week in the protocol. Participants will be instructed to take Epidiolex with a meal rather than in a fasted state. Participants will be treated for 4 weeks in total.

Group II: Placebo Placebo Group 1 Intervention

The placebo will be taken at identical doses to the active drug condition.

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?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

Current evidence does not support the effectiveness of cannabidiol (CBD) for treating acute low back pain, as a clinical trial showed no significant difference compared to placebo.

While there are indications that CBD may help relieve chronic low back pain, the overall evidence is still weak, highlighting the need for more rigorous randomized controlled trials to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can cannabidiol (CBD) help with low back pain? Kulesza, B., Mazurek, M., Kurzepa, J.[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 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 randomized, double-blind, placebo-controlled trial involving 100 patients with acute low back pain, a single dose of 400 mg oral cannabidiol (CBD) did not show superior pain relief compared to a placebo, with similar pain scores reported two hours after administration.

Both groups had comparable lengths of stay in the emergency department and similar usage of rescue analgesia, indicating that CBD did not provide additional benefits in pain management or safety compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The CANBACK trial: a randomised, controlled clinical trial of oral cannabidiol for people presenting to the emergency department with acute low back pain. Bebee, B., Taylor, DM., Bourke, E., et al.[2021]

In a study of 11 patients with failed back surgery syndrome (FBSS) treated with a combination of THC and CBD alongside spinal cord stimulation (SCS) for 12 months, all patients experienced effective pain management, with significant reductions in pain levels from a baseline average of 8.18 to 4.72 on a numeric rating scale (P<0.001).

The combination of THC and CBD demonstrated sustained analgesic effects throughout the treatment period, indicating that cannabinoid agonists can be a valuable adjunct therapy for managing chronic refractory pain in FBSS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabinoids and spinal cord stimulation for the treatment of failed back surgery syndrome refractory pain. Mondello, E., Quattrone, D., Cardia, L., et al.[2022]

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]

Cannabidiol (CBD) has shown potential in treating chronic pain and anxiety by modulating serotonergic transmission, as demonstrated in a rat model of neuropathic pain.

The study found that CBD's pain-relieving effects are mediated by TRPV1 and partially by 5-HT1A receptors, while its anxiety-reducing effects are primarily linked to 5-HT1A receptor activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights on cannabidiol's antiallodynic and anxiolytic mechanisms of action in a model of neuropathic pain. Schott, M.[2020]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Can cannabidiol (CBD) help with low back pain? [2023]

2. 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]

3. 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]

4. Australia pubmed.ncbi.nlm.nih.gov

The CANBACK trial: a randomised, controlled clinical trial of oral cannabidiol for people presenting to the emergency department with acute low back pain. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Cannabinoids and spinal cord stimulation for the treatment of failed back surgery syndrome refractory pain. [2022]

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

Cannabidiol Safety Data: A Systematic Mapping Study. [2023]

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

Insights on cannabidiol's antiallodynic and anxiolytic mechanisms of action in a model of neuropathic pain. [2020]