Cannabidiol for Diabetic Peripheral Neuropathy Pain
This study is testing if Cannabidiol (CBD) or full-spectrum CBD oral solutions can help reduce pain from Diabetic Peripheral Neuropathy (DPN). DPN is a common problem for people with diabetes, causing ongoing pain and numbness. Researchers believe CBD might help by reducing inflammation and oxidative stress. You might be able to join if you are 40 to 70 years old, have Type 2 Diabetes and DPN, and meet certain health requirements, including normal liver function tests. The study aims to enroll 12 to 20 participants. Success will be measured by changes in your DPN pain levels and how severe your neuropathy is over about 15 weeks.
- Study design
- This is a double-blinded, placebo-controlled, crossover pilot study, meaning neither you nor your doctors will know if you are receiving CBD, full-spectrum CBD, or a placebo (an inactive substance). The study plans to enroll 12 to 20 participants.
- What's involved
- You would take an oral solution daily. Your pain levels will be measured at several points over approximately 15 weeks, both at home and at study visits. Your diabetic neuropathy diagnosis and severity will also be assessed at the beginning and end of the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pain levels will be monitored for about 15 weeks (105 days) after starting the study. Your neuropathy severity will be assessed at the end of the study (Day 105).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- DPN Pain LevelBaseline (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 diagnosisBaseline 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 SeverityBaseline, 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