Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study

NCT07298408 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: TMH2025-3175348
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetic Neuropathies; Diabetic Peripheral Neuropathic Pain (DPN)

Keywords

Placebo; Pain Management; Quality of Life; Cross-Over Studies; Double-Blinded Placebo Contolled; Cannabidiol

Outcome Measures

Primary Outcomes (3)

• DPN Pain Level

  Pain level will be assessed using the slightly modified "PainDETECT" Questionnaire. This instrument rates subjective pain 0 - 10 (zero no pain, 10 the worst) for current, average and worst over the last 4 weeks. It additionally scores neuropathic symptoms on a scale of zero to 35, with zero being no symptoms to 35 being the worst.

  Baseline (Day 0), Day 7, Day 21 (at home by subject), Day 35 (at home by subject), End of Phase I (Day 49), Day 63 (at home by subject), Day 77 (at home by subject), End of Phase II (Day 105).

• Diabetic peripheral neuropathy diagnosis

  DPN severity will be assessed using the DN4 Assessment Tool (including a clinical assessment of hypoesthesia and allodynia). The DN4 tool consists of 10 items across four sections, including both patient interview questions and a physical examination. Each "yes" answer receives 1 point, and each "no" answer receives 0 points. The points from all 10 items are summed to get a total score ranging from a minimum of 0 to a maximum of 10. A total score of 4 or more (≥4) suggests the presence of neuropathic pain. A score of 3 or below indicates that neuropathic pain is unlikely. A higher score is associated with worse DPN.

  Baseline Screening (Day 0)

• Diabetic Neuropathy Severity

  The DPNCheck™ instrument will be used to assess sural nerve conduction velocity (NCV) and sensory nerve action potential (SNAP) amplitude. Amplitude, The typical normal ranges are \> 40 m/s for SNAV and \> 4 µV SNAP, though values vary by study; lower values indicate worse neuropathy severity, with thresholds like \\(\<40\\) m/s for SNCV and \\(\<5\\) µV (or even \\(\<4\\) µV) for SNAP signaling mild-to-moderate damage, while amplitudes below 1.5 µV may register as zero due to device limits. Device Limitation: Values below 1.5 µV may be registered as 0 µV. Mild DPN: May show delayed SNCV (\< 40 m/s) or low amplitude. Moderate DPN: Often characterized by reduced SNAP amplitude (e.g., \< 5 µV). Severe DPN: Significant decreases in both amplitude and velocity, with very low or undetectable signals

  Baseline, End of Phase I (Day 49) (for NCT), End of Phase II (Day 91) (for NCT).

Secondary Outcomes (5)

• Sleep Quality

  Periodically over the approximately 4 month study duration

• Mood and Depression

  Periodically over the approximately 4 month study duration

• Quality of Life Index

  Periodically over the approximately 4-month study duration

• Patient Compliance

  End of Phase I (Day 49) End of Phase II (Day 105)

• Liver Function Monitoring (Safety Measure)

  Baseline, (if previous results are > 3 months old), End of Phase II (Day 105)

Study Arms (4)

1. CBD Isolate Phase 1 (Placebo Phase 2)

EXPERIMENTAL

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

Drug: Cannabidiol (CBD) oral solution

2. Placebo Phase 1 (CBD Isolate Phase 2)

PLACEBO COMPARATOR

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.

Drug: Placebo in MCT oil oral solution

3. CBD Full-spectrum Phase 1 (Placebo Phase 2)

EXPERIMENTAL

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.

Drug: Full-Spectrum CBD hemp extract oral solution

4. Placebo Phase 1 (CBD Full-spectrum Phase 2)

PLACEBO COMPARATOR

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.

Drug: Placebo in MCT oil oral solution

Interventions

Placebo in MCT oil oral solution DRUG

Strawberry-flavored medium-chain triglyceride (MCT) oil, administered orally, 30 ml dropper bottle.

2. Placebo Phase 1 (CBD Isolate Phase 2); 4. Placebo Phase 1 (CBD Full-spectrum Phase 2)

Cannabidiol (CBD) oral solution DRUG

Strawberry-flavored Cannabidiol oral solution in medium-chain triglyceride (MCT) oil, administered orally, 100mg/ml in a 30 ml dropper bottle.

1. CBD Isolate Phase 1 (Placebo Phase 2)

Full-Spectrum CBD hemp extract oral solution DRUG

Strawberry-flavored Full-Spectum Cannabidiol oral solution in medium-chain triglyceride (MCT) oil, administered orally, 100mg/ml in a 30 ml dropper bottle.

3. CBD Full-spectrum Phase 1 (Placebo Phase 2)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• History of atrial fibrillation, dysrhythmias, MI within the previous 2 years, or stroke
• 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)
• Elevation of liver enzymes (ALT or AST) exceeding 2 times the ULN, or bilirubin exceeding the ULN
• 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
• Blindness (poor vision preventing questionnaire completion)
• Known allergy or previous adverse reaction to any ingredient, including natural strawberry flavoring
• Reproductive Health (Women Only)
• Currently pregnant or lactating
• Women who can get pregnant who are not using acceptable methods of birth control
• Current uncontrolled mental health conditions (e.g., major depressive episode with active suicidal ideation, bipolar disorder with current manic/hypomanic episode, or psychosis)

Sponsors & Collaborators

• Florida A&M University: lead

Study Sites (1)

the FSU TMH Family Practice Residency Program

Tallahassee, Florida, 32308, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies; Agnosia

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Philip R Treadwell, PharmD

CONTACT

850-431-5714; phillip.treadwell@tmh.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. CBD Isolate Phase 1 Placebo Phase 2 2. CBD Isolate Phase 2 Placebo Phase 1 3. CBD Full-spectrum Phase 1 Placebo Phase 2 4. CBD Full-spectrum Phase 2 Placebo Phase 1 There is a two-weeks washout period between the two phases of the study.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: December 23, 2025
• Study Start: April 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be compiled and prepared for analysis following the completion of the trial and the final follow-up visit (Day 105). The sponsor will reveal the treatment labeling data after the trial for data analysis
• Access Criteria: Access to the coded IPD will be limited to the study team, the Sponsor (Florida A\&M University), and its agents or collaborators (e.g., the funder, Consortium for Medical Marijuana Clinical Outcomes Research (CCORC)) necessary for study conduct, oversight, and data analysis.

Locations

US (1)