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NCT07298408 · ClinicalTrials.gov registry record · Phase 1
Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study
A Phase 1 study, sponsored by Florida A&M University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT07298408: Recruiting Phase 1 study, sponsored by Florida A&M University.
NCT07298408 is a Phase 1 study that is actively recruiting participants, run by Florida A&M University. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07298408, a Phase 1 study, is actively recruiting participants, sponsored by Florida A&M University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
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).
Primary Outcome
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.
Interventions
- DRUG Cannabidiol (CBD) oral solution
- DRUG Full-Spectrum CBD hemp extract oral solution
- DRUG Placebo in MCT oil oral solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-04-02 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 1 |
What NCT07298408 shows while recruiting
NCT07298408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Cannabidiol (CBD) oral solution is the first listed.
NCT07298408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07298408 about?
NCT07298408 is a clinical study titled "Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study". 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)-associate...
What is the current status of trial NCT07298408?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2026-04-02. Estimated completion is 2027-06-30.
What interventions are being tested in trial NCT07298408?
The interventions under investigation include: Cannabidiol (CBD) oral solution (DRUG), Full-Spectrum CBD hemp extract oral solution (DRUG), Placebo in MCT oil oral solution (DRUG).
Who is sponsoring clinical trial NCT07298408?
This trial is sponsored by Florida A&M University, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07298408's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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