Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study

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).

Eligibility

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 complete required questionnaires (adequate vision)

Exclusion Criteria:

1. High-risk or severely ill individuals (e.g., high risk for general anesthesia, significant limitations due to heart/lung disease, ascites, renal failure, loss of limbs from diabetic complications)
2. Uncontrolled or severe cardiovascular disease (e.g., unstable angina, uncontrolled heart failure, recent myocardial infarction)
3. History of atrial fibrillation, dysrhythmias, MI within the previous 2 years, or stroke
4. Severe respiratory illness (e.g., uncontrolled asthma, COPD with frequent exacerbations, oxygen dependence)
5. Severe or uncontrolled liver disease (e.g., cirrhosis, active viral hepatitis A, B, or C, autoimmune hepatitis, uncontrolled primary biliary cholangitis or primary sclerosing cholangitis)
6. Elevation of liver enzymes (ALT or AST) exceeding 2 times the ULN, or bilirubin exceeding the ULN
7. Severe or uncontrolled kidney disease (e.g., end-stage renal disease requiring dialysis, uncontrolled nephrotic syndrome)
8. History of malignancy within the past 5 years (excluding certain low-risk non-melanoma skin cancers)
9. History of a seizure disorder
10. Blindness (poor vision preventing questionnaire completion)
11. Known allergy or previous adverse reaction to any ingredient, including natural strawberry flavoring
12. Reproductive Health (Women Only)
13. Currently pregnant or lactating
14. Women who can get pregnant who are not using acceptable methods of birth control
15. Current uncontrolled mental health conditions (e.g., major depressive episode with active suicidal ideation, bipolar disorder with current manic/hypomanic episode, or psychosis)
16. Diagnosis of a major depressive episode with active suicidal ideation and/or a plan to attempt suicide within the previous 5 years
17. Attempted suicide in the last 10 years
18. C-SSRS Suicide Ideation Subscore ≥5 at study onset
19. HADS-D score ≥15 at study onset
20. Used cannabis products in the past 30 days
21. Current use or history of illicit drug use or misuse of prescription medications within the previous 5 years
22. Heavy drinking (≥8 drinks/week for women; ≥15 drinks/week for men)
23. Taking medications that are known to cross-reacting with CBD or Cannabiods

Conditions3

Interventions3

Locations1 site

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