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CBD oil put to the test for diabetic nerve pain relief

NCT ID NCT07298408

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

40 to 70 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • the FSU TMH Family Practice Residency Program

    RECRUITING

    Tallahassee, Florida, 32308, United States

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