Is NCT07298408 recruiting in Tallahassee, FL?

Yes, NCT07298408 is currently recruiting participants at its Tallahassee, FL location. This diabetic peripheral neuropathic pain (dpn) clinical trial is actively enrolling qualified participants.

Is participation in this Tallahassee clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Diabetic Peripheral Neuropathic Pain (DPN) Clinical Trial in Tallahassee, FL

Q: How do I join the diabetic peripheral neuropathic pain (dpn) clinical trial in Tallahassee?

To join this clinical trial in Tallahassee, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Diabetic Peripheral Neuropathic Pain (DPN) Study in Tallahassee

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).

Sponsor: Florida A&M University

Who Can Participate

Inclusion 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)

Exclusion Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Tallahassee?

Yes, this clinical trial (NCT07298408) has an active research site in Tallahassee, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Diabetic Peripheral Neuropathic Pain (DPN) Treatment Options in Tallahassee, FL

If you're searching for diabetic peripheral neuropathic pain (dpn) treatment options in Tallahassee, FL, this clinical trial (NCT07298408) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Tallahassee research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diabetic peripheral neuropathic pain (dpn) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all diabetic peripheral neuropathic pain (dpn) clinical trials near you to find additional studies recruiting in your area.

Diabetic Peripheral Neuropathic Pain (DPN) Clinical Trial in Tallahassee, FL

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