Debra Kimless, M.D, Matthew K. Caloura* and Stephen Goldner, Esq
Background: This is a prospective, randomized, dose-controlled, double-blind, placebo-controlled phase II clinical study for the treatment of patients with painful diabetic peripheral neuropathy (pDPN) of the feet. Safety of cannabidiol (CBD) sublingual tablets was the primary objective. Efficacy of the proprietary water-solubilized CBD sublingual tablets on pain, sleep quality and anxiety were the secondary objectives. This trial was conducted remotely with a 28-day dosing regimen.
Methods: Subjects who met all inclusion/exclusion criteria and a Numerical Pain Rating Scale (NPRS) score of 5 or greater were recruited to participate. Trial subjects were randomized to receive either a 20 mg CBD sublingual tablet or placebo tablet three times a day (TID) for 28 days. Subjects were instructed to answer daily and weekly questions on the provided smart phone application.
Results: Subjects taking the CBD tablet reported statistically and clinically significant pain reduction from baseline as compared with placebo. They also had significantly more favorable Patient Global Impression of Change (PGIC) scores than the placebo group. Subjects in the CBD group met the Minimal Clinically Important Difference (MCID) for sleep improvement as compared with the placebo group. Clinically significant reduction in anxiety was also reported by subjects in the CBD group.
Conclusions: The results demonstrate that a proprietary formulation of water-solubilized 20 mg CBD sublingual tablets taken TID can achieve significant pain relief in chronic diabetics with pDPN, along with an improvement in sleep and anxiety reduction, without any tablet related adverse effects.
This study is listed on ClinicalTrials.Gov, ID: NCT04679545