14
Participants
Start Date
March 1, 2023
Primary Completion Date
May 1, 2024
Study Completion Date
December 1, 2024
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)."
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)"
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.
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.
St. Joseph's Health Care London - Parkwood Institute, London
Ontario Neurotrauma Foundation
OTHER
Eldon Loh, MD
OTHER