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Taking people in United StatesPhase 1/2

Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study

Key facts

Who runs it
Florida A&M University
Where
Tallahassee, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 1/2
People taking part
20 people, planned
Started
2 Apr 2026
Expected to end
30 Jun 2027
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Cannabidiol (CBD) oral solution
  • Full-Spectrum CBD hemp extract oral solution
  • Placebo in MCT oil oral solution
Record updated
29 April 2026

Who can take part

Age
40 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 34 criteriaShow less

Who can take part

  • Adult aged 40 to 70 years
  • Diagnosis of Type 2 Diabetes
  • Ambulatory and independently living adult
  • Minimum body weight of 50 kg (to ensure daily dose ≤2 mg/kg)
  • Physical exam completed within the previous 6 months
  • Liver Function Studies (ALT and AST) completed within the previous six months showing normal values
  • If NAFLD is present, ALT and AST levels are ≤2 times the Upper Limit of Normal (ULN)
  • DN4 questionnaire results indicate mild to moderate DPN
  • Nerve Conduction Test (NCT) confirms at least mild DPN
  • Signed ICF/Screening Consent
  • Able to complete required questionnaires (adequate vision)

Who cannot take part

  • History of atrial fibrillation, dysrhythmias, MI within the previous 2 years, or stroke
  • Known allergy or previous adverse reaction to any ingredient, including natural strawberry flavoring
  • Diagnosis of a major depressive episode with active suicidal ideation and/or a plan to attempt suicide within the previous 5 years
  • Current use or history of illicit drug use or misuse of prescription medications within the previous 5 years
  • Taking medications that are known to cross-reacting with CBD or Cannabiods
  • 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)
  • Uncontrolled or severe cardiovascular disease (e.g., unstable angina, uncontrolled heart failure, recent myocardial infarction)
  • Severe respiratory illness (e.g., uncontrolled asthma, COPD with frequent exacerbations, oxygen dependence)
  • 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)
  • Severe or uncontrolled kidney disease (e.g., end-stage renal disease requiring dialysis, uncontrolled nephrotic syndrome)
  • History of malignancy within the past 5 years (excluding certain low-risk non-melanoma skin cancers)
  • History of a seizure disorder
  • Current uncontrolled mental health conditions (e.g., major depressive episode with active suicidal ideation, bipolar disorder with current manic/hypomanic episode, or psychosis)
  • Elevation of liver enzymes (ALT or AST) exceeding 2 times the ULN, or bilirubin exceeding the ULN
  • Blindness (poor vision preventing questionnaire completion)
  • Reproductive Health (Women Only)
  • Currently pregnant or lactating
  • Women who can get pregnant who are not using acceptable methods of birth control
  • Attempted suicide in the last 10 years
  • C-SSRS Suicide Ideation Subscore ≥5 at study onset
  • HADS-D score ≥15 at study onset
  • Used cannabis products in the past 30 days
  • Heavy drinking (≥8 drinks/week for women; ≥15 drinks/week for men)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 70 years old?

Where in United States

  • the FSU TMH Family Practice Residency ProgramTallahassee, United StatesContact: Justin LeeTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 4 groups in the trial

  • 1. CBD Isolate Phase 1 (Placebo Phase 2)Treatment being tested

    Participants randomized to Arm 1 will be given CBD Isolate tincture 100 mg/ml (50 mg twice daily for a total of 100 mg daily) for 6 weeks in Phase 1. After a 2-week washout period they will be given an identical appearing placebo tincture for an additional 6 weeks. The bottles will be labeled: "TMH CBD for DPN Trial: (number) A" and "TMH CBD for DPN Trial: (number)B", where A refers to the vials to be used in phase one and B to the vials used for phase two. Since a vial contains a 30-day supply and each phase lasts 42 days, the participants will receive two identically labelled vials at the beginning of each phase.1

    Treatment: Cannabidiol (CBD) oral solution

  • 2. Placebo Phase 1 (CBD Isolate Phase 2)Placebo, for comparison

    Participants randomized to Arm 2 will be given a placebo tincture (0.5 ml twice daily for a total of 1 ml daily) for 6 weeks in Phase 1. After a 2-week washout period, they will be given the active tincture containing 100 mg of CBD isolate (100 mg/ ml) to use 0.5 ml twice daily for an additional 6 weeks. The bottles will be labeled: "TMH CBD for DPN Trial: (number) A" and "TMH CBD for DPN Trial: (number)B", where A refers to the vials to be used in phase one and B to the vials used for phase two. Since a vial contains a 30-day supply and each phase lasts 42 days, the participants will receive two identically labelled vials at the beginning of each phase.

    Treatment: Placebo in MCT oil oral solution

  • 3. CBD Full-spectrum Phase 1 (Placebo Phase 2)Treatment being tested

    Participants randomized to Arm 3 will be given a Full-spectrum CBD isolate tincture with 100 mg of hemp-derived CBD isolate /ml (using 0.5 ml; 50 mg twice daily for a total of 100 mg daily) for 6 weeks in Phase 1. After a 2-week washout period they will be given an identical appearing placebo tincture for an additional 6 weeks. The bottles will be labeled: "TMH CBD for DPN Trial: (number) A" and "TMH CBD for DPN Trial: (number)B", where A refers to the vials to be used in phase one and B to the vials used for phase two. Since a vial contains a 30-day supply and each phase lasts 42 days, the participants will receive two identically labelled vials at the beginning of each phase.

    Treatment: Full-Spectrum CBD hemp extract oral solution

  • 4. Placebo Phase 1 (CBD Full-spectrum Phase 2)Placebo, for comparison

    Participants randomized to Arm 4 will be given a placebo tincture (0.5 ml twice daily for a total of 1 ml daily) for 6 weeks in Phase 1. After a 2-week washout period, they will be given the active tincture containing 100 mg of CBD Full-spectrum isolate (100 mg/ ml) to use 0.5 ml twice daily for an additional 6 weeks. The bottles will be labeled: "TMH CBD for DPN Trial: (number) A" and "TMH CBD for DPN Trial: (number)B", where A refers to the vials to be used in phase one and B to the vials used for phase two. Since a vial contains a 30-day supply and each phase lasts 42 days, the participants will receive two identically labelled vials at the beginning of each phase.

    Treatment: Placebo in MCT oil oral solution

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT07298408, who can take part
Record updated
29 April 2026