CBD oil put to the test for diabetic nerve pain relief
NCT ID NCT07298408
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study is testing whether CBD oil can help reduce pain and nerve damage in people with diabetic peripheral neuropathy (DPN). About 20 adults with mild to moderate DPN will receive either CBD or a placebo for 6 weeks. The goal is to see if CBD is safe and effective, and to gather data for a larger future study.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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the FSU TMH Family Practice Residency Program
RECRUITINGTallahassee, Florida, 32308, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Electric pulses may bring back lost foot sensation in diabetes
- Can a numbing gel on the feet beat a daily pill for diabetic nerve pain?
- A heart drug takes on diabetic nerve pain: can trimetazidine turn the tide?
- Can gentle electrical pulses revive damaged nerves in diabetes?
- A ZAP BEHIND THE KNEE MAY QUIET DIABETIC NERVE PAIN