Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study

Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study (NCT07298408) is a Phase 1 / Phase 2 interventional studying Diabetic Peripheral Neuropathic Pain (DPN) and Diabetic Neuropathies, sponsored by Florida A&M University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Diabetic Peripheral Neuropathic Pain (DPN), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Inclusion Criteria 1. Adult aged 40 to 70 years 2. Diagnosis of Type 2 Diabetes 3. Ambulatory and independently living adult 4. Minimum body weight of 50 kg (to ensure daily dose ≤2 mg/kg) 5. Physical exam completed within the previous 6 months 6. Liver Function Studies (ALT and AST) completed within the previous six months showing normal values 7. If NAFLD is present, ALT and AST levels are ≤2 times the Upper Limit of Normal (ULN) 8. DN4 questionnaire results indicate mild to moderate DPN 9. Nerve Conduction Test (NCT) confirms at least mild DPN 10. Signed ICF/Screening Consent 11. Able to complete required questionnaires (adequate vision) Who Should NOT Join This Trial: 1. 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) 2. Uncontrolled or severe cardiovascular disease (e.g., unstable angina, uncontrolled heart failure, recent myocardial infarction) 3. History of atrial fibrillation, dysrhythmias, MI within the previous 2 years, or stroke 4. Severe respiratory illness (e.g., uncontrolled asthma, COPD with frequent exacerbations, oxygen dependence) 5. 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) 6. Elevation of liver enzymes (ALT or AST) exceeding 2 times the ULN, or bilirubin exceeding the ULN 7. Severe or uncontrolled kidney disease (e.g., end-stage renal disease requiring dialysis, uncontrolled nephrotic syndrome) 8. History of malignancy within the past 5 years (excluding certain low-risk non-melanoma skin cancers) 9. History of a seizure disorder 10. Blindness (poor vision preventing questionnaire completion) 11. Known allergy or previous adverse reaction to any ingredient, including natural strawberry flavoring 12. Reproductive Health (Women Only) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria 1. Adult aged 40 to 70 years 2. Diagnosis of Type 2 Diabetes 3. Ambulatory and independently living adult 4. Minimum body weight of 50 kg (to ensure daily dose ≤2 mg/kg) 5. Physical exam completed within the previous 6 months 6. Liver Function Studies (ALT and AST) completed within the previous six months showing normal values 7. If NAFLD is present, ALT and AST levels are ≤2 times the Upper Limit of Normal (ULN) 8. DN4 questionnaire results indicate mild to moderate DPN 9. Nerve Conduction Test (NCT) confirms at least mild DPN 10. Signed ICF/Screening Consent 11. Able to complete required questionnaires (adequate vision) Exclusion Criteria: 1. 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) 2. Uncontrolled or severe cardiovascular disease (e.g., unstable angina, uncontrolled heart failure, recent myocardial infarction) 3. History of atrial fibrillation, dysrhythmias, MI within the previous 2 years, or stroke 4. Severe respiratory illness (e.g., uncontrolled asthma, COPD with frequent exacerbations, oxygen dependence) 5. 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) 6. Elevation of liver enzymes (ALT or AST) exceeding 2 times the ULN, or bilirubin exceeding the ULN 7. Severe or uncontrolled kidney disease (e.g., end-stage renal disease requiring dialysis, uncontrolled nephrotic syndrome) 8. History of malignancy within the past 5 years (excluding certain low-risk non-melanoma skin cancers) 9. History of a seizure disorder 10. Blindness (poor vision preventing questionnaire completion) 11. Known allergy or previous adverse reaction to any ingredient, including natural strawberry flavoring 12. Reproductive Health (Women Only) 13. Currently pregnant or lactating 14. Women who can get pregnant who are not using acceptable methods of birth control 15. Current uncontrolled mental health conditions (e.g., major depressive episode with active suicidal ideation, bipolar disorder with current manic/hypomanic episode, or psychosis) 16. Diagnosis of a major depressive episode with active suicidal ideation and/or a plan to attempt suicide within the previous 5 years 17. Attempted suicide in the last 10 years 18. C-SSRS Suicide Ideation Subscore ≥5 at study onset 19. HADS-D score ≥15 at study onset 20. Used cannabis products in the past 30 days 21. Current use or history of illicit drug use or misuse of prescription medications within the previous 5 years 22. Heavy drinking (≥8 drinks/week for women; ≥15 drinks/week for men) 23. Taking medications that are known to cross-reacting with CBD or Cannabiods

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

the FSU TMH Family Practice Residency Program

Tallahassee, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07298408), the sponsor (Florida A&M University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07298408 clinical trial studying?

Who can participate in NCT07298408?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07298408?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07298408. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07298408. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.