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

Last updated on July 2021

Recruitment

Recruitment Status: Not yet recruiting
Estimated Enrollment: 144

Summary

Conditions

Neuropathic Pain
Spinal Cord Injuries

Type

Interventional

Phase

Phase 3

Design

Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: Eligible participants who consent to study participation will be randomized to one of four groups: 1) Nabilone and Placebo Diet, 2) Placebo Capsule and Anti-inflammatory Diet, 3) Nabilone and Anti-inflammatory Diet, and 4) Placebo Capsule and Placebo Diet. Following randomization, participants will begin a study agent titration period (nabilone or placebo) in order to determine a safe and effective nabilone dose for each participant. Once the appropriate nabilone (or placebo) dosage for each participant is determined, participants will begin their respective interventions over the course of the 12-week treatment period. All outcome measures will be assessed baseline, post-testing (following the 12-week treatment period) as well as at a follow-up testing session 3-months following the cessation of the intervention.Masking: Triple (Participant, Care Provider, Investigator)Masking Description: No other parties will be masked for the study.Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 125 years
Gender: Both males and females

Description

Nabilone and an anti-inflammatory diet are two novel treatments that may be beneficial for managing Neuropathic Pain (NP) after Spinal Cord Injury (SCI). Neuropathic pain is a common complication following 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. Cannabinoids and an anti-inflammatory diet may provide pain relief while being better tolerated. The Co- Sponsor Investigators will test the potential benefits of these treatments for neuropathic pain after SCI. Clinically, cannabinoids have been shown to be effective in the management of central NP after multiple sclerosis (MS), and although they have been trialed for a variety of complications after SCI, direct evidence for their ability to manage NP in this population is limited. Further, no studies have evaluated the efficacy of synthetic cannabinoids (nabilone) for the treatment of NP after SCI. Accordingly, the CanPainSCI Clinical Practice Guidelines concluded that the evidence is insufficient to develop a specific recommendation regarding cannabinoids in the treatment of NP after SCI. In addition, relevant side effects for those with SCI have not been well documented. Despite this, cannabinoids have been increasingly used as a treatment option for NP after SCI, particularly given increased access to, and greater societal acceptance of, cannabinoids in general. Studies that evaluate the effectiveness and side effects of cannabinoids and synthetic cannabinoids in the SCI population are therefore urgently needed. An anti-inflammatory diet has recently shown promise in the management of NP after SCI. An RCT comparing an anti-inflammatory diet to placebo identified a reduction in sensory NP symptoms following SCI. This RCT was done in a general population of SCI patients and did not necessarily select those who were experiencing significant neuropathic pain. Therefore, additional evidence to demonstrate treatment effect will be important to justify widespread adoption of this diet for NP after SCI. The study will collect data on a sample of up to 140 patients with SCI and at- and/or below-level neuropathic pain >3/10 in severity on the numeric rating scale. The Principal Investigators will assess the treatment's effects on quality of life and pain management. If the study is successful, the results (and an evaluation of the process) will be used to inform an affordable and sustainable anti-inflammatory nutrition program to be implemented at Power Cord. This nutrition program will also be widely disseminated and potentially act as a template for similar programs In SCI care centres across Canada. This study will assess blood samples at three time points for analysis of pro and anti-inflammatory markers. The research coordinator (blinded to the randomization) will assess patients using various quality of life and pain assessment questionnaires during clinic visits, at home or by telephone interview. The type, level, and completeness of injury will be documented, and, if necessary, updated at each in-person visit. Each participant will be provided with instructions and study schedule. Protocol compliance will be tested through product count and interviews at each follow-up visit. Side effects will be assessed using standardized case report forms at each visit. Study visits may be in person or over the phone. Participants will be encouraged to report any events they may experience directly to the coordinator. Participants who withdraw consent to continue treatments, will be encouraged to undergo the planned assessments. Withdrawal at the request of investigators or medical personnel may include, but are not limited to: Symptoms are deemed to be potentially related to the study product New diagnosis of exclusion criteria; Unacceptable side effects; Death Estimated time to complete recruitment: Averaging 36 months, approximately 3 years.

Tracking Information

NCT #: NCT04057456
Collaborators: Ontario Neurotrauma Foundation
Investigators: Principal Investigator: Eldon Loh, MD Lawson Health Research Institute Principal Investigator: David Ditor, MD Brock University