Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy

Launched by DARTMOUTH-HITCHCOCK MEDICAL CENTER · Dec 21, 2020

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ClinConnect Summary

This clinical trial is studying a medication called Low-Dose Naltrexone (LDN) to see if it can help relieve pain in people suffering from painful diabetic neuropathy, a common complication of diabetes that causes severe pain in the legs and feet. The trial is looking for adults over 18 years old who have been diagnosed with this condition for more than six months and have not found relief with at least one standard treatment, like Gabapentin or Duloxetine. It is important that participants do not have other causes of nerve pain and are stable on their current non-opioid pain medications.

Participants in the trial will be randomly assigned to receive either LDN or a placebo (a dummy treatment with no active medication) to compare the effects. The trial aims to find out if LDN can effectively reduce pain and improve quality of life for those with painful diabetic neuropathy. This study is particularly important as it seeks to provide a safe, non-opioid option for pain management, addressing the growing concern around opioid use and addiction. If you think you might qualify and are interested, it could be a great opportunity to explore a new treatment option.

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Eligibility 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 (The Diagnostic and Statistical Manual of Mental Disorders)
• • 4. Current treatment for substance use disorder or alcohol use disorder
• • 5. Current opioid therapy or on opioid therapy within the past 1 month