What side effects are associated with this type of intervention?

Common side effects of cannabinoid treatments (THC, CBD, THC+CBD) for diabetic neuropathy include dizziness, dry mouth, nausea, fatigue, and changes in appetite. There may also be cognitive impairment, mood changes, and potential for dependency. These side effects are consistent with those observed in broader studies of cannabinoids for chronic pain management.

What prior FDA approvals exist?

The FDA has not approved any cannabinoid-based treatments specifically for diabetic neuropathy. However, cannabinoids like THC and CBD are being studied for their potential to modulate pain perception and inflammation through interaction with the endocannabinoid system. Currently, treatments for diabetic neuropathy primarily include anticonvulsants (e.g., pregabalin, gabapentin), antidepressants (e.g., duloxetine, amitriptyline), and topical agents (e.g., capsaicin). These treatments focus on different mechanisms of action, such as modulating neurotransmitter levels and reducing nerve pain, rather than directly interacting with the endocannabinoid system.

What other types of research exist?

Promising, novel alternatives to cannabinoids for diabetic neuropathy in 2024 include: 1. Topical lidocaine, which blocks sodium channels to reduce pain signaling. 2. Capsaicin patches, which deplete substance P involved in pain transmission. 3. Botulinum toxin injections, which inhibit acetylcholine release to reduce muscle spasticity and pain. Additionally, enhanced glycemic control, exercise, and pharmacological agents like pregabalin and gabapentin remain important strategies.

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Cannabinoid

Cannabis Derivatives for Diabetic Neuropathy

Phase 2

Recruiting

Led By Donald McGeary, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet criteria for persistent, high-impact pain criteria.

Veterans 21 years and older at the date of screening

Must not have

Primary source of pain not related to diabetic neuropathy

Opioid doses > 400 mg MME (morphine milligram equivalent)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8

Summary

This trial tests if cannabis derivatives (THC, CBD, and their combination) can reduce chronic diabetic nerve pain in Veterans. Veterans often don't get enough relief from standard treatments, so this study aims to find out if cannabis can help. The trial will test if these cannabis compounds are effective. Cannabis has been studied for its potential to alleviate pain in various conditions, including diabetic neuropathy, but its long-term safety and efficacy remain uncertain.

Who is the study for?

This trial is for Veterans aged 21+ with diabetic neuropathic pain who can consent to participate. They must have allodynia, meet NEURODIAB criteria for painful diabetic peripheral neuropathy, and experience persistent high-impact pain. Excluded are federal employees, those needing psychiatric hospitalization, pregnant or breastfeeding women, individuals using cannabis products or with a recent history of Cannabis Use Disorder.

What is being tested?

The study tests the effects of THC (Dronabinol), CBD (Epidolex), their combination (Nabiximols), and placebo on chronic diabetic neuropathic pain in Veterans. It's a phase II trial with four groups randomly assigned in a double-blind manner to determine potential benefits and adverse effects.

What are the potential side effects?

Possible side effects include hypersensitivity reactions to THC/CBD, changes in mood or behavior due to THC use such as euphoria or sedation, digestive issues like nausea or diarrhea from CBD intake, and general discomfort that may arise from either substance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience constant, severe pain.

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I am a veteran aged 21 or older.

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I have been diagnosed with painful nerve damage due to diabetes.

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I experience constant, severe pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My main source of pain is not due to diabetic nerve damage.

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I take more than 400 mg of pain medication in morphine equivalents daily.

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I do not have any severe health issues that could increase my risk during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To compare the short-term efficacy of THC, CBD, or THC+CBD vs Placebo on Neuropathic Pain as measured by the Numeric Rating Scale of Pain

Secondary study objectives

Cannabidiol

To assess the efficacy of THC, CBD, or THC+CBD vs Placebo in disability and function as measured by the Gait Speed Test

To assess the efficacy of THC, CBD, or THC+CBD vs Placebo in disability and function as measured by the Neuropathic Pain Scale.

+8 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: THC (Syndros)Active Control2 Interventions

Target dose of 10mg per day.

Group II: CBD (Epidolex)Active Control2 Interventions

Target dose of 800 mg per day.

Group III: THC + CBD (Nabiximols)Active Control2 Interventions

Target dose of 10.8 mg / 10 mg per day.

Group IV: PlaceboPlacebo Group1 Intervention

Identical in appearance to the three active comparators.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Diabetic Neuropathy include cannabinoids (THC, CBD, THC+CBD), gabapentinoids, antidepressants, and topical agents. Cannabinoids interact with the endocannabinoid system to modulate pain perception and reduce inflammation, which can be particularly beneficial for neuropathic pain. Gabapentinoids, such as gabapentin, work by inhibiting calcium channels to reduce neuronal excitability and pain transmission. Antidepressants, like duloxetine, increase the levels of neurotransmitters (serotonin and norepinephrine) that help modulate pain. Topical agents, such as capsaicin and lidocaine, provide localized pain relief by desensitizing pain receptors and blocking sodium channels, respectively. These mechanisms are crucial for Diabetic Neuropathy patients as they address the chronic pain and inflammation associated with the condition, improving their quality of life.