CBD for Chronic Radicular Pain on Chronic Opioid Therapy (COT)

Overseen By Angela West, MA

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: NYU Langone Health

Must be taking: Opioid analgesics

Must not be taking: Benzodiazepines, Methadone, THC, others

Disqualifiers: Substance use disorder, Severe psychiatric, others

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether taking 600mg of CBD daily can help reduce pain in people with chronic spinal nerve pain who are already on stable opioid medications. The study will last for a short period, and researchers will compare the effects of CBD to see if it is safe and effective.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of opioid medication for at least one month before starting. However, you cannot participate if you are taking certain medications that interact with CBD, such as those metabolized by specific liver enzymes or those known to have adverse interactions with CBD.

Is cannabidiol (CBD) generally safe for human use?

Research shows that CBD is generally well tolerated in humans, but it can cause some side effects like diarrhea, decreased appetite, and sleepiness. There are also concerns about liver function, especially when CBD is used with other medications, so it's important to monitor these interactions. ^{1 2 3 4 5}

How does the drug Cannabidiol differ from other treatments for this condition?

Cannabidiol (CBD) is unique because it is a non-psychotropic component of cannabis, meaning it doesn't cause a 'high', and it has been shown to suppress immune responses, which may be beneficial in conditions like multiple sclerosis. Unlike other treatments, CBD can be administered in various forms, such as orally or topically, and has been studied for its potential to reduce inflammation and improve symptoms in autoimmune conditions. ^{5 6 7 8 9}

Who Is on the Research Team?

Stephen Ross, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Inclusion Criteria

Diagnosis of radicular CNCP (i.e. lumbar, cervical, thoracic)

Males and females aged ≥18

Maintained on stable dose opioid therapy for a minimum of 1 month

Exclusion Criteria

Pregnancy or lactation

Current significant suicidality (assessed using the C-SSRS), any suicidal behavior in the past 12 months, or any history of suicide attempts

Current use of recreational or medical cannabis or any product containing CBD

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive daily oral CBD 600mg or placebo for 2 weeks

2 weeks

Baseline visit, Week 2 visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol
• Placebo

How Is the Trial Designed?

Group I: Cannabidiol (CBD) Active Control 1 Intervention

Group II: Placebo (PCB) 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?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

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 clinical trials involving 803 participants found that cannabidiol (CBD) is associated with a higher likelihood of withdrawal due to adverse effects compared to placebo, particularly in studies related to childhood epilepsy.

While CBD generally appears well tolerated, significant adverse effects such as abnormal liver function tests and sedation were noted, especially in combination with other medications, highlighting the need for careful monitoring of drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. Chesney, E., Oliver, D., Green, A., et al.[2021]

A systematic review of 51 clinical studies indicates that cannabidiol (CBD) is generally well tolerated in humans, with most adverse events (AEs) being mild to moderate, such as diarrhea and sedation.

While serious AEs are rare, they can occur, particularly when CBD is taken with other medications, highlighting the need for careful monitoring of drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on Cannabidiol Clinical Toxicity and Adverse Effects: A Systematic Review. Madeo, G., Kapoor, A., Giorgetti, R., et al.[2023]

In a study involving 20 healthy Beagle dogs, repeated oral administration of plant-derived cannabidiol (CBD) was well tolerated, with no significant safety concerns noted over 28 days, although higher doses (12 mg/kg) led to mild gastrointestinal side effects.

The pharmacokinetics of CBD showed a dose-dependent increase in systemic exposure and plasma concentrations, reaching steady state after two weeks, which can inform future dosing strategies for CBD in veterinary medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, placebo-controlled, 28-day safety and pharmacokinetics evaluation of repeated oral cannabidiol administration in healthy dogs. Vaughn, DM., Paulionis, LJ., Kulpa, JE.[2021]

Topical application of a 1% CBD-cream significantly reduced the clinical symptoms of autoimmune encephalomyelitis (EAE) in mice, improving hind limb paralysis and decreasing disease severity compared to untreated EAE mice.

The CBD-cream treatment also showed neuroprotective effects by reducing inflammation markers and T cell activation in the spinal cord and spleen, suggesting its potential as a therapeutic option for managing multiple sclerosis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new formulation of cannabidiol in cream shows therapeutic effects in a mouse model of experimental autoimmune encephalomyelitis. Giacoppo, S., Galuppo, M., Pollastro, F., et al.[2018]

In a pilot study involving 12 patients with multiple sclerosis, the use of a THC/CBD oromucosal spray significantly reduced spasticity symptoms, as indicated by a decrease in the Numerical Rating Scale (NRS) scores from a median of 6 to 3.5 (P < 0.001).

The study found a significant correlation between the plasma concentrations of THC and CBD and the reduction in spasticity, suggesting that higher levels of these cannabinoids in the blood are associated with greater clinical effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tetrahydrocannabinol/Cannabidiol Oromucosal Spray in Patients With Multiple Sclerosis: A Pilot Study on the Plasma Concentration-Effect Relationship. Contin, M., Mancinelli, L., Perrone, A., et al.[2018]

Citations

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

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

2. England pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. [2021]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Update on Cannabidiol Clinical Toxicity and Adverse Effects: A Systematic Review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Lack of evidence for the effectiveness or safety of over-the-counter cannabidiol products. [2021]

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

Randomized, placebo-controlled, 28-day safety and pharmacokinetics evaluation of repeated oral cannabidiol administration in healthy dogs. [2021]

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

Cannabidiol attenuates delayed-type hypersensitivity reactions via suppressing T-cell and macrophage reactivity. [2021]

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

A new formulation of cannabidiol in cream shows therapeutic effects in a mouse model of experimental autoimmune encephalomyelitis. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Placebo effects in a multiple sclerosis spasticity enriched clinical trial with the oromucosal cannabinoid spray (THC/CBD): dimension and possible causes. [2020]

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

Tetrahydrocannabinol/Cannabidiol Oromucosal Spray in Patients With Multiple Sclerosis: A Pilot Study on the Plasma Concentration-Effect Relationship. [2018]