Pilot Study of Cannabidiol and Full-Spectrum CBD Tinctures for Treating Pain from Diabetic Peripheral Neuropathy in Adults Aged 40 to 70

What this Trial Is About

Researchers are evaluating the effects of cannabidiol CBD and full-spectrum CBD fsCBD tinctures on pain caused by diabetic peripheral neuropathy DPN, a common and distressing complication of diabetes characterized by chronic pain and sensory loss. This pilot study is double-blinded, placebo-controlled, and uses a crossover design to assess the potential neuroprotective and pain-relieving properties of CBD by regulating inflammation and oxidative stress. The study aims to refine the clinical protocol and assess patient compliance while generating data for future larger trials. Participants with mild to moderate DPN will receive either CBD isolate, full-spectrum CBD, or placebo tinctures in two sequential 6-week phases separated by a 2-week washout. The daily dose for active treatment is 100 mg of CBD given as 50 mg twice daily, administered orally in medium-chain triglyceride MCT oil with strawberry flavoring to maintain blinding. Four randomized arms ensure each participant receives both active and placebo treatments over the study periods. During the approximately 4-month study, participants will attend clinic visits at baseline, mid-study, end of each phase, and a follow-up call after completion. Assessments include nerve conduction tests using a needleless device, physical exams, and validated questionnaires measuring pain, mood, sleep quality, and quality of life. Compliance is monitored by returned medication volume and questionnaire completion. Safety includes liver function monitoring and tracking of adverse events, with withdrawal criteria for worsening cardiovascular or neuropsychiatric symptoms.

Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study