Cannabidiol for Radiculopathy

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether CBD, a compound found in cannabis, can reduce chronic radicular pain in individuals on stable doses of opioid painkillers. Participants will receive either CBD or a placebo to determine which provides better pain relief. It suits those with chronic spinal pain who have maintained the same opioid dosage for at least a month. The trial aims to assess if CBD is safe, tolerable, and effective in managing pain compared to a placebo. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

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

Research has shown that cannabidiol (CBD) is usually safe for use. Some studies have found that CBD can cause side effects, often mild, such as fatigue, appetite changes, or diarrhea. It's important to note that CBD can interact with other medications, so discussing it with a doctor is advised. Reports of liver problems, particularly with high doses or when combined with certain drugs, have occurred but remain rare.

As this trial is in its early stages, the main goal is to ensure the treatment's safety and understand how the body processes it. This phase involves careful monitoring. For those considering joining the trial, it's reassuring to know that safety is the top priority. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for chronic radicular pain, which often rely on opioids, cannabidiol (CBD) offers a non-opioid alternative that may reduce pain without the risk of addiction. Researchers are excited about CBD because it interacts with the body's endocannabinoid system, which plays a role in pain modulation, potentially offering relief with fewer side effects. Additionally, CBD's anti-inflammatory properties might address the underlying causes of pain, unlike opioids that primarily mask the symptoms. This novel approach could provide a safer, more sustainable pain management option.

What evidence suggests that this treatment might be an effective treatment for chronic spinal radiculopathies?

Research has shown that CBD, which participants in this trial may receive, might help manage chronic pain. Studies have found that CBD can reduce pain by 42% to 66% in many cases. Researchers consider it a safe and non-toxic treatment. Besides easing pain, CBD has also helped some people with anxiety and trouble sleeping. While more research is always helpful, these findings suggest that CBD could be a promising option for those with chronic nerve pain. ^{6 7 8 9 10}

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

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7880228/

Therapeutic Efficacy of Cannabidiol (CBD): A Review of the ... CBD also exhibited significant protracted effects on craving (800 mg) and anxiety (400 and 800 mg), seven days after the drug was last ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165178124003342

Therapeutic potential of cannabidiol (CBD) in anxiety ... While CBD has shown significant efficacy in relieving anxiety symptoms overall, its efficacy appears to vary depending on the specific disease subtype being ...

3. 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.

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1356009/full

Cannabidiol usage, efficacy, and side effects Overall, nearly 70% of the individuals found CBD products to be effective. Sublingual administration was more popular among non-cannabis users, ...

5. 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.

6. sigmaaldrich.com sigmaaldrich.com/US/en/sds/SIAL/C6395?srsltid=AfmBOorzQoaq8vy4xAN6qFfU8vgj-af20CnvFUC_tmkuiJDmycDNHm6Q

SAFETY DATA SHEET OSHA: No component of this product present at levels greater than or equal to 0.1% is on OSHA's list of regulated carcinogens. Reproductive ...

7. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/90080m.pdf

Safety Data Sheet Article number: 90080. · Application of the substance / the mixture. This product is for research use - Not for human or veterinary diagnostic ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36251454/

Cannabidiol Safety Data: A Systematic Mapping Study We have developed the first systematic map of the safety-related information available for CBD in the peer-reviewed literature.

9. library.samhsa.gov library.samhsa.gov/sites/default/files/pep22-06-04-003.pdf

Cannabidiol (CBD) – Potential Harms, Side Effects, and ... Potential risks and harms associated with CBD use include adverse drug interactions, liver toxicity, and reproductive and developmental effects.

10. chemos.de chemos.de/import/data/msds/GB_en/13956-29-1-A0039825-GB-en.pdf

Cannabidiol - Safety Data Sheet Does not contain an endocrine disruptor (EDC) in a concentration of ≥ 0,1%. SECTION 3: Composition/information on ingredients. 3.1. Substances. Name of ...