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Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study

NCT07298408 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-29

No results posted yet for this study

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 Peripheral Neuropathic Pain (DPN)
  • Diabetic Neuropathies

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.

Sponsors & Collaborators

  • Florida A&M University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-02
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07298408 on ClinicalTrials.gov