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Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study

Status: Recruiting

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 1/Phase 2

SUMMARY

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).

Eligibility

Participation Requirements

Sex: All

Minimum Age: 40

Maximum Age: 70

Healthy Volunteers: f

View:

• 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)

Locations

United States

Florida

the FSU TMH Family Practice Residency Program

RECRUITING

Tallahassee

Contact Information

Primary

Philip R Treadwell, PharmD

phillip.treadwell@tmh.org

850-431-5714

Time Frame

Start Date: 2026-04-02

Estimated Completion Date: 2027-06-30

Participants

Target number of participants: 20

Treatments

Experimental: 1. CBD Isolate Phase 1 (Placebo Phase 2)

Participants randomized to Arm 1 will be given CBD Isolate tincture 100 mg/ml (50 mg twice daily for a total of 100 mg daily) for 6 weeks in Phase 1. After a 2-week washout period they will be given an identical appearing placebo tincture for an additional 6 weeks. The bottles will be labeled: TMH CBD for DPN Trial: (number) A and TMH CBD for DPN Trial: (number)B, where A refers to the vials to be used in phase one and B to the vials used for phase two. Since a vial contains a 30-day supply and each phase lasts 42 days, the participants will receive two identically labelled vials at the beginning of each phase.1

Placebo_comparator: 2. Placebo Phase 1 (CBD Isolate Phase 2)

Participants randomized to Arm 2 will be given a placebo tincture (0.5 ml twice daily for a total of 1 ml daily) for 6 weeks in Phase 1. After a 2-week washout period, they will be given the active tincture containing 100 mg of CBD isolate (100 mg/ ml) to use 0.5 ml twice daily for an additional 6 weeks. The bottles will be labeled: TMH CBD for DPN Trial: (number) A and TMH CBD for DPN Trial: (number)B, where A refers to the vials to be used in phase one and B to the vials used for phase two. Since a vial contains a 30-day supply and each phase lasts 42 days, the participants will receive two identically labelled vials at the beginning of each phase.

Experimental: 3. CBD Full-spectrum Phase 1 (Placebo Phase 2)

Participants randomized to Arm 3 will be given a Full-spectrum CBD isolate tincture with 100 mg of hemp-derived CBD isolate /ml (using 0.5 ml; 50 mg twice daily for a total of 100 mg daily) for 6 weeks in Phase 1. After a 2-week washout period they will be given an identical appearing placebo tincture for an additional 6 weeks. The bottles will be labeled: TMH CBD for DPN Trial: (number) A and TMH CBD for DPN Trial: (number)B, where A refers to the vials to be used in phase one and B to the vials used for phase two. Since a vial contains a 30-day supply and each phase lasts 42 days, the participants will receive two identically labelled vials at the beginning of each phase.

Placebo_comparator: 4. Placebo Phase 1 (CBD Full-spectrum Phase 2)

Participants randomized to Arm 4 will be given a placebo tincture (0.5 ml twice daily for a total of 1 ml daily) for 6 weeks in Phase 1. After a 2-week washout period, they will be given the active tincture containing 100 mg of CBD Full-spectrum isolate (100 mg/ ml) to use 0.5 ml twice daily for an additional 6 weeks. The bottles will be labeled: TMH CBD for DPN Trial: (number) A and TMH CBD for DPN Trial: (number)B, where A refers to the vials to be used in phase one and B to the vials used for phase two. Since a vial contains a 30-day supply and each phase lasts 42 days, the participants will receive two identically labelled vials at the beginning of each phase.

Related Therapeutic Areas

Chronic Pain

Diabetic Neuropathy

Peripheral Neuropathy

Neuralgia