Cannabidiol to treat pain from diabetic peripheral neuropathy (pilot)

Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study

This pilot tests whether daily oral cannabidiol or full‑spectrum CBD tinctures reduce pain in adults 40–70 with mild-to-moderate diabetic peripheral neuropathy.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: Florida A&M University (Academic / other)
• Locations: 1 site (Tallahassee, Florida)
• Trial ID: NCT07298408 on ClinicalTrials.gov

What this trial studies

This double‑blinded, placebo‑controlled crossover pilot randomizes 12–20 adults with mild-to-moderate diabetic peripheral neuropathy to receive either CBD isolate, full‑spectrum CBD, or placebo delivered as an oral MCT‑oil tincture. Each participant completes two sequential 6‑week treatment phases with dosing at 50 mg twice daily (100 mg/day). The trial operates under an FDA IND and emphasizes methodological endpoints to inform larger trials while also measuring changes in neuropathic pain and quality of life. Safety monitoring includes liver function tests and exclusion criteria for significant cardiovascular or systemic illness.

Who should consider this trial

Good fit: Adults aged 40–70 with Type 2 diabetes, ambulatory, weighing at least 50 kg, and with mild‑to‑moderate DPN confirmed by DN4 questionnaire and nerve conduction testing are ideal candidates.

Not a fit: People with severe or advanced diabetic complications, uncontrolled cardiovascular disease, significant organ failure, or who fall outside the study age/weight or liver‑function limits are unlikely to benefit from this pilot.

Why it matters

Potential benefit: If successful, CBD could offer a non‑psychoactive option to reduce neuropathic pain and improve quality of life for people with diabetic peripheral neuropathy.

How similar studies have performed: Preclinical models and limited human data suggest cannabinoids may reduce neuropathic pain, but rigorous randomized trials of oral CBD specifically for DPN are sparse, so this approach remains largely unproven in patients.

Eligibility criteria

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

Where this trial is running

Tallahassee, Florida

• the FSU TMH Family Practice Residency Program — Tallahassee, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Philip R Treadwell, PharmD

Conditions Diabetic Peripheral Neuropathic Pain; Diabetic Neuropathies; Placebo; Pain Management; Quality of Life; Cross-Over Studies; Double-Blinded Placebo Contolled; Cannabidiol