Cannabidiol for Diabetic Neuropathy

(CBD-DPN1 Trial)

Overseen By Philip R Treadwell, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Florida A&M University

Must not be taking: Cannabis, Cannabinoids

Disqualifiers: Severe cardiovascular, Respiratory, Liver, Kidney, others

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Cannabidiol (CBD) can reduce pain from Diabetic Peripheral Neuropathy (DPN), a painful condition caused by nerve damage from diabetes. Participants will receive either a CBD tincture or a placebo to determine if CBD offers better pain relief than current options. Researchers aim to discover if CBD can protect nerves and reduce pain by decreasing inflammation and stress in the body. The trial seeks adults with Type 2 Diabetes who have mild to moderate nerve pain. As a Phase 1, Phase 2 trial, this research focuses on understanding how CBD works in people and measuring its effectiveness in an initial group, offering a unique opportunity to contribute to groundbreaking pain management research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those taking medications that interact with CBD. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CBD (cannabidiol) and full-spectrum CBD (fsCBD) may help manage symptoms of diabetic peripheral neuropathy (DPN). Earlier studies found that CBD significantly reduced pain and other symptoms in diabetic cases. Importantly, CBD is usually well-tolerated, with reports indicating few serious side effects when used for various conditions, including neuropathy.

For fsCBD, similar safety results have been observed. Studies suggest that fsCBD may help reduce diabetes-related pain. While side effects can occur, they are generally mild, such as fatigue or dry mouth.

The current trial phase indicates that these CBD treatments are still in the early stages of testing for DPN. While earlier studies have shown their safety, more research is needed to confirm these results specifically for DPN. Participants can feel reassured by the existing data suggesting that CBD treatments are generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Cannabidiol (CBD) for diabetic neuropathy because it's derived from the cannabis plant and offers a natural alternative to conventional treatments like pain relievers or anticonvulsants. Unlike traditional medications, which mainly mask the pain, CBD might reduce inflammation and protect nerve cells, potentially addressing the root cause of the pain. The study explores both CBD isolate and full-spectrum CBD, which includes other beneficial cannabinoids, possibly enhancing the therapeutic effects. This could provide a more holistic option with fewer side effects compared to standard pharmaceuticals.

What evidence suggests that this trial's treatments could be effective for diabetic neuropathy?

Studies have shown that cannabidiol (CBD) may help reduce pain in people with diabetic peripheral neuropathy (DPN). Research suggests that CBD might work by reducing inflammation and stress that can damage nerves. In animal studies, CBD improved symptoms related to DPN, indicating it might help humans too. Some studies with cannabis, which contains CBD, have shown it can reduce pain from diabetic neuropathy. This trial examines both pure CBD and full-spectrum CBD (which includes other compounds from the cannabis plant) for these benefits. While more research is needed, these early findings are promising. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate Diabetic Peripheral Neuropathy (DPN), a painful condition from diabetes. Participants should be experiencing chronic pain and sensory loss. Key eligibility details are not provided, so it's assumed that typical criteria apply: no conflicting health conditions or medications, and willingness to follow the study protocol.

Inclusion Criteria

Nerve Conduction Test (NCT) confirms at least mild DPN

Signed ICF/Screening Consent

Able to complete required questionnaires (adequate vision)

Exclusion Criteria

I do not have severe kidney disease or need dialysis.

Women who can get pregnant who are not using acceptable methods of birth control

I am unable to complete questionnaires due to poor vision.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase I

Participants receive either CBD isolate or full-spectrum CBD or placebo for 6 weeks

6 weeks

3 visits (in-person) at Day 0, Day 7, and Day 49

Washout

A 2-week washout period between treatment phases

2 weeks

Treatment Phase II

Participants receive the alternate treatment (CBD or placebo) for another 6 weeks

6 weeks

1 visit (in-person) at Day 91

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 phone follow-up at Day 105

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

Trial Overview

The study tests Cannabidiol (CBD) and full-spectrum CBD in MCT oil against a placebo for DPN pain relief. It's double-blinded, meaning neither participants nor researchers know who gets what treatment. Each person tries both the real medicine and placebo in two 6-week phases to see if there's any improvement.

How Is the Trial Designed?

Group I: 3. CBD Full-spectrum Phase 1 (Placebo Phase 2) Experimental Treatment 1 Intervention

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.

Group II: 1. CBD Isolate Phase 1 (Placebo Phase 2) Experimental Treatment 1 Intervention

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

Group III: 2. Placebo Phase 1 (CBD Isolate Phase 2) Placebo Group 1 Intervention

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.

Group IV: 4. Placebo Phase 1 (CBD Full-spectrum Phase 2) Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Florida A&M University

Lead Sponsor

Trials

8

Recruited

5,100+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07298408

Cannabidiol for the Treatment of Diabetic Peripheral ...

Preclinical data further suggests CBD significantly improves behavioral DPN parameters in diabetic rat models and positively regulates ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11666268/

Efficacy and Safety of Transdermal Medical Cannabis ...

This novel transdermal medical cannabis formulation (THC:CBD:CBN) demonstrated significant therapeutic efficacy in ameliorating painful DPN symptoms while ...

3.

withpower.com

withpower.com/trial/phase-2-diabetic-peripheral-neuropathic-pain-dpn-2026-e448f

Cannabidiol for Diabetic Neuropathy (CBD-DPN1 Trial)

CBD and fsCBD are being investigated for their potential neuroprotective and analgesic effects by regulating inflammation and oxidative stress.

4.

mdpi.com

mdpi.com/2227-9059/13/10/2406

Long-Term Efficacy and Safety of Inhaled Cannabis ...

Research evidence demonstrates that THC and CBD, along with their natural cannabis source, produce pain relief effects when tested in diabetic pain models and ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04679545

Using Cannabidiol to Treat Diabetic Peripheral Neuropathy ...

Study Overview. The purpose of the study is to evaluate whether PG-DN-20WS is a better pain reliever in patients with diabetic neuropathic pain of the feet ...

6.

researchgate.net

researchgate.net/publication/371300465_Safety_and_efficacy_of_cannabidiol_in_the_management_of_chemotherapy-induced_peripheral_neuropathy

Safety and efficacy of cannabidiol in the management ...

Nielsen et al. [11] reported that oral CBD (300 mg/day) was able to attenuate early symptoms of CIPN in cancer survivors compared with untreated controls. .

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10582612/

The pharmacology and therapeutic role of cannabidiol in ...

This work summarizes the role of CBD in diabetes and its impact on complications such as cardiovascular dysfunction, nephropathy, retinopathy, and neuropathy.