Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study
Florida A&M University
Summary
The "Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot study (CBD-DPN1)" is a double-blinded, placebo-controlled, crossover pilot study evaluating the efficacy of Cannabidiol (CBD) and full-spectrum CBD (fsCBD) tinctures in treating Diabetic Peripheral Neuropathy (DPN)-associated pain. DPN is a common, highly distressing complication of diabetes, characterized by chronic pain and loss of sensory function, for which currently available treatments primarily offer only symptomatic relief. CBD and fsCBD are being investigated for their potential neuroprotective and analgesic effects by regulating inflammation and oxidative stress. The study aims to recruit 12 to 20 adult participants who have mild to moderate DPN. Subjects will receive either an active treatment (CBD isolate or fsCBD in MCT oil, dosed at 50 mg twice daily for a total of 100 mg daily) or a placebo during two sequential 6-week phases. The overall objective of this pilot phase is primarily methodological: to test and refine the clinical protocol, assess patient compliance and acceptability of the CBD formulations, and generate sufficient data to calculate the necessary sample size for a larger, definitive study. Efficacy will be measured using objective and subjective metrics, including DPN severity (DN4 Assessment Tool and DPNCheck™ for nerve conduction velocity) and pain level (PainDetect Questionnaire). Secondary outcomes include evaluating mood (HADS), sleep quality (MOS Sleep Scale), and quality of life (EQ-5D-5L).
Description
The Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot study (CBD-DPN1) is an interventional, double-blinded, placebo-controlled, crossover pilot study investigating the efficacy of cannabidiol (CBD) formulations in treating diabetic peripheral neuropathy (DPN)-associated pain. This study operates under an Investigational New Drug (IND) application cleared by the U.S. Food and Drug Administration (FDA). Scientific Rationale and Objectives DPN is a widespread and highly distressing complication of Type 2 Diabetes (T2D), leading to chronic pain, numbness, and significant los…
Eligibility
- Age range
- 40–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Adult aged 40 to 70 years 2. Diagnosis of Type 2 Diabetes 3. Ambulatory and independently living adult 4. Minimum body weight of 50 kg (to ensure daily dose ≤2 mg/kg) 5. Physical exam completed within the previous 6 months 6. Liver Function Studies (ALT and AST) completed within the previous six months showing normal values 7. If NAFLD is present, ALT and AST levels are ≤2 times the Upper Limit of Normal (ULN) 8. DN4 questionnaire results indicate mild to moderate DPN 9. Nerve Conduction Test (NCT) confirms at least mild DPN 10. Signed ICF/Screening Consent 11. Able to c…
Interventions
- DrugCannabidiol (CBD) oral solution
Strawberry-flavored Cannabidiol oral solution in medium-chain triglyceride (MCT) oil, administered orally, 100mg/ml in a 30 ml dropper bottle.
- DrugFull-Spectrum CBD hemp extract oral solution
Strawberry-flavored Full-Spectum Cannabidiol oral solution in medium-chain triglyceride (MCT) oil, administered orally, 100mg/ml in a 30 ml dropper bottle.
- DrugPlacebo in MCT oil oral solution
Strawberry-flavored medium-chain triglyceride (MCT) oil, administered orally, 30 ml dropper bottle.
Location
- the FSU TMH Family Practice Residency ProgramTallahassee, Florida