Using cannabinoids and an anti-inflammatory diet to treat neuropathic pain after spinal cord injury

Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury

This study is testing if a synthetic cannabis drug and an anti-inflammatory diet can help people with nerve pain after a spinal cord injury feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 25 Years and up
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Academic / other)
• Locations: 1 site (London, Ontario)
• Trial ID: NCT04057456 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of nabilone, a synthetic cannabinoid, and an anti-inflammatory diet in managing neuropathic pain following spinal cord injury. Participants will be randomly assigned to receive either the anti-inflammatory diet or a placebo diet, along with nabilone or a placebo for a duration of four weeks. The study aims to determine if these treatments can significantly reduce pain intensity and improve functional outcomes for individuals suffering from neuropathic pain. The combination of both interventions is hypothesized to yield greater benefits than either treatment alone.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 25 and over with a spinal cord injury lasting at least 12 months and experiencing moderate to severe neuropathic pain.

Not a fit: Patients with acute spinal cord injuries or those with pain levels below the study's threshold may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel, well-tolerated treatment option for patients suffering from neuropathic pain after spinal cord injury.

How similar studies have performed: While cannabinoids have shown promise in managing neuropathic pain in other conditions, this specific combination of nabilone and an anti-inflammatory diet has not been extensively tested, making it a novel approach.

Eligibility criteria

Inclusion:

1. Age 25 and over, based on year of birth
2. Signed informed consent obtained prior to any study-related activities
3. BMI 18-40
4. A spinal cord injury at least 12 months duration, nonprogressive for at least 6 months
5. At- and/or below-level neuropathic pain \>3/10 in severity on the numeric rating scale (NRS) (below-level neuropathic pain will be defined as pain \>1 dermatomal level below the neurologic level of injury). Participants will need an average \>3/10 pain over the past 7 days on screening, and to complete a daily diary for the week prior to randomization in the morning with an average pain severity of \>3/10 on at least 4 diary entries.
6. Ongoing constant pain for at least 3 months, or relapsing/remitting pain for at least 6 months.
7. Dosing of other pain medications (NSAIDs, opioids, non-opioid analgesics, anti-epileptic drugs, antidepressants) should be stable for at least 1 month prior to study entry.
8. Any cannabinoids, or cannabinoid medications (e.g. nabilone) will need to be stopped at least 1 month prior to screening for and inclusion in the study.
9. Females of childbearing potential must agree to use a medically approved method of birth control (e.g. hormonal contraceptives, intrauterine devices, vasectomy/tubal ligation, barrier methods and double-barrier method) and must have a negative pregnancy test results at screening and baseline.

Exclusion:

1. History of psychotic disorder
2. History of convulsive disorders
3. History of substance abuse
4. experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months
5. Significantly impaired hepatic function at Visit A1 or B1 (Alanine aminotransferase \[ALT\] \>5 upper limit of normal \[ULN\] or total bilirubin \[TBL\] \>2 ULN) OR the ALT or Aspartate aminotransferase (AST) \>3 ULN and TBL \>2 ULN (or international normalized ratio \[INR\] \>1.5)
6. Female patients of child bearing potential and male patients whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception, during the study and for three months thereafter
7. Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter
8. Current suicidal ideation
9. Current use of cannabinoids or cannabinoid medication
10. Intolerance to cannabinoids
11. Traumatic SCI superimposed on prior congenital stenosis
12. Preexisting myelopathy of other causes (e.g. transverse myelitis, epidural abscess, congenital spondylotic myelopathy)
13. Presence of other neurologic conditions, medical conditions or pain that could confound the assessment of neuropathic pain after SCI
14. Currently enrolled in another clinical trial
15. Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient's ability to participate in the study
16. Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study

Where this trial is running

London, Ontario

• St. Joseph's Health Care London - Parkwood Institute — London, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Eldon Loh, MD — London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
• Study coordinator: Eldon Loh, MD

Conditions Spinal Cord Injuries; Neuropathic Pain; Nabilone; Spinal Cord Injury; Neuropathic pain; Pain; Anti Inflammatory Diet