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New treatment option for Diabetic Peripheral Neuropathic Pain (DPN)
Official title Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study
ClinicalTrials.gov ID: NCT07298408
What this study is testing
What is Cannabidiol (CBD) oral solution?
Cannabidiol (CBD) oral solution is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diabetic peripheral neuropathic pain (dpn).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70
You may be able to join if
- Adult aged 40 to 70 years
- Diagnosis of Type 2 Diabetes
- Ambulatory and independently living adult
- Minimum body weight of 50 kg (to ensure daily dose ≤2 mg/kg)
- Physical exam completed within the previous 6 months
You likely can't join if
- High-risk or severely ill individuals (e.g., high risk for general anesthesia, significant limitations due to heart/lung disease, ascites, renal...
- Uncontrolled or severe cardiovascular disease (e.g., unstable angina, uncontrolled heart failure, recent myocardial infarction)
- History of atrial fibrillation, dysrhythmias, MI within the previous 2 years, or stroke
- Severe respiratory illness (e.g., uncontrolled asthma, COPD with frequent exacerbations, oxygen dependence)
- Severe or uncontrolled liver disease (e.g., cirrhosis, active viral hepatitis A, B, or C, autoimmune hepatitis, uncontrolled primary biliary...
- Elevation of liver enzymes (ALT or AST) exceeding 2 times the ULN, or bilirubin exceeding the ULN
See the full eligibility criteria
- Adult aged 40 to 70 years
- Diagnosis of Type 2 Diabetes
- Ambulatory and independently living adult
- Minimum body weight of 50 kg (to ensure daily dose ≤2 mg/kg)
- Physical exam completed within the previous 6 months
- Liver Function Studies (ALT and AST) completed within the previous six months showing normal values
- If NAFLD is present, ALT and AST levels are ≤2 times the Upper Limit of Normal (ULN)
- DN4 questionnaire results indicate mild to moderate DPN
- Nerve Conduction Test (NCT) confirms at least mild DPN
- Signed ICF/Screening Consent
- Able to complete required questionnaires (adequate vision)
- 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)
- Uncontrolled or severe cardiovascular disease (e.g., unstable angina, uncontrolled heart failure, recent myocardial infarction)
- History of atrial fibrillation, dysrhythmias, MI within the previous 2 years, or stroke
- Severe respiratory illness (e.g., uncontrolled asthma, COPD with frequent exacerbations, oxygen dependence)
- 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)
- Elevation of liver enzymes (ALT or AST) exceeding 2 times the ULN, or bilirubin exceeding the ULN
- Severe or uncontrolled kidney disease (e.g., end-stage renal disease requiring dialysis, uncontrolled nephrotic syndrome)
- History of malignancy within the past 5 years (excluding certain low-risk non-melanoma skin cancers)
- History of a seizure disorder
- Blindness (poor vision preventing questionnaire completion)
- Known allergy or previous adverse reaction to any ingredient, including natural strawberry flavoring
- Reproductive Health (Women Only)
- Currently pregnant or lactating
- Women who can get pregnant who are not using acceptable methods of birth control
- Current uncontrolled mental health conditions (e.g., major depressive episode with active suicidal ideation, bipolar disorder with current manic/hypomanic episode, or psychosis)
- Diagnosis of a major depressive episode with active suicidal ideation and/or a plan to attempt suicide within the previous 5 years
- Attempted suicide in the last 10 years
- C-SSRS Suicide Ideation Subscore ≥5 at study onset
- HADS-D score ≥15 at study onset
- Used cannabis products in the past 30 days
- Current use or history of illicit drug use or misuse of prescription medications within the previous 5 years
- Heavy drinking (≥8 drinks/week for women; ≥15 drinks/week for men)
- Taking medications that are known to cross-reacting with CBD or Cannabiods
The study team makes the final eligibility decision.
Where it's taking place
- Tallahassee, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tallahassee, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.