Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabetes affects more than 30 million people in the United States and is a leading cause of morbidity. Over 25% diabetics also suffer from debilitating painful diabetic neuropathy in the lower legs and feet. This pain can be severe, difficult to control, and have a significant negative impact on quality of life. Opioid medications have historically been a mainstay of treatment for this pain, despite the risks. As the death toll from the U.S. opioid epidemic continues to rise, the need for quality alternative non-opioid medications to treat pain becomes more urgent. One of these potential medications is Low-Dose Naltrexone (LDN). This drug is reported to work by enhancing the body's natural pain relieving mechanisms and decreases inflammation by targeting specific cells called microglia which have been shown to influence chronic pain. LDN has been shown to be a safe medication with minimal side effects. Its efficacy has been demonstrated in other painful conditions but has never been fully studied for treating painful diabetic neuropathy. The goal of this randomized, placebo-controlled trial is to determine if LDN is effective for treating the pain caused by diabetic neuropathy. LDN's mechanism of action is well suited to treating painful diabetic neuropathy, and LDN shows significant promise as a safe, non-opioid alternative that can decrease pain and improve quality of life for those suffering from this painful condition.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

1. Diagnosis of Painful Diabetic Neuropathy (PDN) for >6 months

2. Has failed at least one prior standard treatment for PDN (Gabapentin, duloxetine, etc)

3. No other known causes of lower extremity neuropathic pain

4. Subjects capable of giving informed consent

5. Greater than 18 years of age

6. Stable on all current non-opioid pain medication for at least 1 month

7. English as primary language

Exclusion Criteria:

1. Known allergy to naltrexone or naloxone

2. Presence of known causes of lower extremity neuropathic pain not attributed to PDN

3. Active substance use disorder or alcohol use disorder as defined by DSM-V

4. Current treatment for substance use disorder or alcohol use disorder

5. Current opioid therapy or on opioid therapy within the past 1 month