Debra Kimless, M.D., Matthew K. Caloura*, Ara Kirakosyan, Ph.D., and Stephen Goldner, Esq
Background: This is a prospective, open-label, drug and dose-controlled study. The primary objective of this study is to evaluate the safety and efficacy of cannabidiol (CBD) sublingual tablets for the treatment of patients with chronic diabetic neuropathic pain. The secondary objects are to evaluate the impact of CBD tablets on sleep quality and anxiety. We describe the effectiveness data at the completion of a 21-day study.
Methods: Subjects who met all inclusion/exclusion criteria and met the prespecified minimum Numerical Pain Rating Scale (NPRS) score were eligible for participation. Thirty-one subjects with chronic diabetic neuropathic pain were recruited. Patients were instructed to take CBD sublingual tablets three times a day and were taught to use a smart phone data collection application to record daily NPRS scores.
Results: At the conclusion of the study, patients reported significant reduction in pain from baseline. The secondary endpoints analysing the effects of the CBD tablets on sleep quality and anxiety score revealed statistically significant improvement in both. No adverse drug reactions were reported.
Conclusions: Our findings demonstrate that the sublingual application of CBD tablets can achieve significant reduction in pain, as well as significant improvement in sleep quality and a reduction in anxiety and without any adverse drug reactions in patients with diabetic peripheral neuropathy.