Actively Recruiting
Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study
Led by Florida A&M University · Updated on 2026-04-29
20
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 70 years
- Diagnosed with Type 2 Diabetes
- Able to walk and live independently
- Body weight at least 50 kg
- Physical exam completed within the last 6 months
- Normal liver function tests (ALT and AST) within the last 6 months
- If Non-Alcoholic Fatty Liver Disease (NAFLD) is present, liver enzymes (ALT and AST) are no more than 2 times the upper limit of normal
- DN4 questionnaire indicating mild to moderate diabetic peripheral neuropathy
- Nerve conduction test confirming at least mild diabetic peripheral neuropathy
- Signed informed consent form
- Able to complete questionnaires (adequate vision)
You will not qualify if you...
- High-risk or severely ill individuals (e.g., high risk for anesthesia, serious heart or lung disease, ascites, kidney failure, limb loss from diabetes)
- Uncontrolled or severe cardiovascular disease (unstable angina, heart failure, recent heart attack)
- History of atrial fibrillation, arrhythmias, heart attack within 2 years, or stroke
- Severe respiratory illness (uncontrolled asthma, COPD with frequent flare-ups, oxygen dependence)
- Severe or uncontrolled liver disease (cirrhosis, active viral hepatitis, autoimmune liver diseases)
- Liver enzymes (ALT or AST) more than twice the upper limit of normal or elevated bilirubin
- Severe or uncontrolled kidney disease (end-stage requiring dialysis, severe nephrotic syndrome)
- History of cancer within past 5 years (except certain low-risk skin cancers)
- History of seizure disorder
- Blindness preventing questionnaire completion
- Allergy or adverse reaction to any study ingredient including strawberry flavoring
- Pregnant or breastfeeding women
- Women of childbearing potential not using acceptable birth control
- Uncontrolled mental health conditions (major depression with suicidal thoughts, bipolar disorder, psychosis)
- Major depressive episode with suicidal ideation or plan in past 5 years
- Suicide attempt in past 10 years
- High suicide risk score at study start
- High depression score at study start
- Cannabis use in past 30 days
- History or current illicit drug use or prescription drug misuse in past 5 years
- Heavy alcohol use (8 or more drinks/week women; 15 or more drinks/week men)
- Taking medications known to interfere with CBD metabolism or effects
AI-Screening
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Trial Site Locations
Total: 1 location
1
the FSU TMH Family Practice Residency Program
Tallahassee, Florida, United States, 32308
Actively Recruiting
Research Team
P
Philip R Treadwell, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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