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
25 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult aged 40 to 70 years
- Diagnosis of Type 2 Diabetes
- Ambulatory and independently living adult
- Minimum body weight of 50 kg
- Physical exam completed within the previous 6 months
- Normal liver function tests (ALT and AST) within the previous 6 months
- If Non-Alcoholic Fatty Liver Disease is present, ALT and AST levels no more than 2 times the upper limit of normal
- Mild to moderate diabetic peripheral neuropathy confirmed by DN4 questionnaire
- Nerve conduction test confirming at least mild diabetic peripheral neuropathy
- Signed informed consent form
- Able to complete required questionnaires with adequate vision
You will not qualify if you...
- High-risk or severely ill individuals (e.g., significant heart/lung disease, ascites, renal failure, limb loss from diabetic complications)
- Uncontrolled or severe cardiovascular disease (e.g., unstable angina, heart failure, recent heart attack)
- History of atrial fibrillation, dysrhythmias, recent myocardial infarction, or stroke
- Severe respiratory illness or oxygen dependence
- Severe or uncontrolled liver disease (e.g., cirrhosis, active viral hepatitis, autoimmune hepatitis)
- Liver enzyme or bilirubin levels exceeding specified limits
- Severe or uncontrolled kidney disease requiring dialysis
- History of cancer within past 5 years (excluding some skin cancers)
- History of seizure disorder
- Blindness preventing questionnaire completion
- Allergy or adverse reaction to study ingredients including strawberry flavor
- Currently pregnant or lactating
- Women able to become pregnant not using birth control
- Uncontrolled mental health conditions including major depression with suicidal ideation
- Suicide attempt within last 10 years
- High suicide ideation scores at study start
- Cannabis use in past 30 days
- Recent illicit drug use or misuse of prescriptions
- Heavy alcohol use
- Taking medications that interact with cannabidiol or cannabinoids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 14 weeks (6 weeks treatment Phase I, 2 weeks washout, 6 weeks treatment Phase II)
Participants receive two 6-week treatment periods with cannabidiol (CBD) or placebo oral solutions in a randomized crossover design, separated by a 2-week washout period.
4 clinic visits (Day 0, Day 7, Day 49, Day 91)
Duration - 2 weeks
Participants complete a phone follow-up to assess safety and study completion.
1 phone follow-up visit (Day 105)
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here