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

PHASE3CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

March 1, 2023

Primary Completion Date

May 1, 2024

Study Completion Date

December 1, 2024

Conditions
Spinal Cord InjuriesNeuropathic Pain
Interventions
OTHER

Placebo diet

"The dietitian will assist in developing a diet that is isocaloric to the anti-inflammatory diet and healthy (for the sake of the participants' well-being, and to blind participants), while allowing many foods that are (counterintuitively) pro-inflammatory (e.g. whole wheat bread, white beans, oats, soy, eggplant, raspberries, pumpkin seeds, popcorn, etc). Occasional cheat foods are built into the placebo diet but with more pro-inflammatory options (e.g. two glasses of wine per week)."

OTHER

Anti-inflammatory diet

"Participants will also be given a list of foods that they are allowed on the anti-inflammatory diet, and a list of foods to avoid so that they can make informed substitutions to the meals and ingredients that they are given. The study participants will be given a one-week meal plan with accompanying recipes. Occasional cheat foods are built into the anti-inflammatory diet (e.g. two bottles of beer per week)"

DRUG

Nabilone Capsules

Capsules will be 0.5mg nabilone. Participants will undergo a 5-week titration period by taking 1 (0.5mg) nabilone capsule per day for a three-day period. The dose will be increased on a fixed schedule by 1 (0.5mg) capsule every three days to a maximum of 8 capsules/day (4mg). Dosage will be maintained if higher doses are not tolerated or if sufficient relief is obtained (at least a 2-point change on the NRS). Once the appropriate nabilone (or placebo) dosage for each participant is determined, participants will begin their respective interventions over the course of the 4-week treatment period.

OTHER

Placebo capsules

Placebo capsules contain no active ingredient. Participants on placebo capsules will undergo the same 5-week titration period and intervention period as those on active treatment.

Trial Locations (1)

N6C 0A7

St. Joseph's Health Care London - Parkwood Institute, London

All Listed Sponsors
collaborator

Ontario Neurotrauma Foundation

OTHER

lead

Eldon Loh, MD

OTHER