Cannabinoids + Anti-inflammatory Diet for Neuropathic Pain
(CATNP Trial)
Trial Summary
What is the purpose of this trial?
Neuropathic pain is a common complication following spinal cord injury (SCI) that significantly decreases quality of life. Treatment options are limited, and current treatments can have significant side effects. Those with SCI have identified a need for additional treatment options, particularly those that are not medications. Nabilone and an anti-inflammatory diet are two treatments that may provide pain relief while being better tolerated. This study will evaluate the benefits of these treatments for neuropathic pain after SCI. Study participants will receive either an anti-inflammatory diet or a placebo diet, and nabilone or a placebo for 4 weeks. It is expected that an anti-inflammatory diet and nabilone will significantly decrease pain intensity and improve function. The combination of both treatments together is expected to have a greater effect than each alone.
Do I have to stop taking my current medications for the trial?
You need to stop taking any cannabinoids or cannabinoid medications at least 1 month before the study. Other pain medications should be stable for at least 1 month before joining the study.
What data supports the idea that Cannabinoids + Anti-inflammatory Diet for Neuropathic Pain is an effective treatment?
The available research shows that dietary bioactive compounds, which are part of an anti-inflammatory diet, can reduce inflammation and pain in neuropathic pain. Animal studies suggest these compounds help reduce pain by affecting certain pathways in the body. Additionally, medical cannabis has been shown to alleviate neuropathic pain and improve physical conditions in specific cases, such as diabetic neuropathic cachexia. While human studies are limited, these findings suggest that combining cannabinoids with an anti-inflammatory diet could be effective for managing neuropathic pain.12345
What safety data exists for cannabinoids and anti-inflammatory diets in treating neuropathic pain?
Cannabinoids, including THC/CBD combinations and nabilone, have been evaluated for safety in treating neuropathic pain. They generally have a favorable safety profile compared to other medications, with common side effects like euphoria, drowsiness, and dizziness, and a low likelihood of severe adverse reactions or abuse. The Mediterranean diet, often considered an anti-inflammatory diet, is generally safe and associated with various health benefits, though specific safety data in the context of neuropathic pain is limited.678910
Is the anti-inflammatory diet and Nabilone drug a promising treatment for neuropathic pain?
Research Team
Eldon Loh, MD
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
David Ditor, MD
Principal Investigator
Brock University
Eligibility Criteria
Adults over 25 with a stable spinal cord injury for at least a year, experiencing neuropathic pain. They must not be pregnant or planning pregnancy, have used cannabinoids recently, or have certain medical conditions like liver issues or psychotic disorders. Stable dosing of other pain meds is required and they must agree to use birth control.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either an anti-inflammatory diet or a placebo diet, and nabilone or a placebo for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Anti-inflammatory diet (Other)
- Nabilone Capsules (Cannabinoid)
- Placebo capsules (Other)
- Placebo diet (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eldon Loh, MD
Lead Sponsor
Ontario Neurotrauma Foundation
Collaborator