NCT07298408 · Florida A&M University
Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study
(CBD-DPN1)
What this study is about
The "Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot study (CBD-DPN1)" is a double-blinded, compared against an inactive treatment, crossover pilot study evaluating the effectiveness of Cannabidiol (CBD) and full-spectrum CBD (fsCBD) tinctures in treating Diabetic Peripheral Neuropathy (DPN)-associated pain.
View original scientific description
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).
Interventions
DRUG
Cannabidiol (CBD) oral solution
Strawberry-flavored Cannabidiol oral solution in medium-chain triglyceride (MCT) oil, administered orally, 100mg/ml in a 30 ml dropper bottle.
DRUG
Full-Spectrum CBD hemp extract oral solution
Strawberry-flavored Full-Spectum Cannabidiol oral solution in medium-chain triglyceride (MCT) oil, administered orally, 100mg/ml in a 30 ml dropper bottle.
DRUG
Placebo in MCT oil oral solution
Strawberry-flavored medium-chain triglyceride (MCT) oil, administered orally, 30 ml dropper bottle.
Primary outcome measures
DPN Pain Level
Time frame: 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).
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.
Diabetic peripheral neuropathy diagnosis
Time frame: Baseline Screening (Day 0)
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.
Diabetic Neuropathy Severity
Time frame: Baseline, End of Phase I (Day 49) (for NCT), End of Phase II (Day 91) (for NCT).
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Exclusion criteria
- 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)
- Diagnosis of a major depressive episode with active suicidal ideation and/or a plan to attempt suicide within the previous 5 years
- 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
- Current use or history of illicit drug use or misuse of prescription medications within the previous 5 years
- Heavy drinking (≥8 drinks/week for women; ≥15 drinks/week for men)
- Taking medications that are known to cross-reacting with CBD or Cannabiods
Where
- Tallahassee, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 29, 2026 · Source of record for eligibility and locations