Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy
About this trial
This is an interventional treatment trial for Painful Diabetic Neuropathy focused on measuring Low-Dose Naltrexone, Painful Diabetic Neuropathy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Painful Diabetic Neuropathy (PDN) for >6 months
- Has failed at least one prior standard treatment for PDN (Gabapentin, duloxetine, etc)
- No other known causes of lower extremity neuropathic pain
- Subjects capable of giving informed consent
- Greater than 18 years of age
- Stable on all current non-opioid pain medication for at least 1 month
- English as primary language
Exclusion Criteria:
- Known allergy to naltrexone or naloxone
- Presence of known causes of lower extremity neuropathic pain not attributed to PDN
- Active substance use disorder or alcohol use disorder as defined by DSM-V (The Diagnostic and Statistical Manual of Mental Disorders)
- Current treatment for substance use disorder or alcohol use disorder
- Current opioid therapy or on opioid therapy within the past 1 month
Sites / Locations
- Dartmouth-Hitchcock Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group A, Low-Dose Naltrexone, Then Placebo
Group B, Placebo, Then Low-Dose Naltrexone
Group A will receive active drug (Naltrexone 1 capsule by mouth daily, 1.5mg x1 week, 3mg x1 week, and 4.5 mg x6 weeks) for the first 8 weeks. Capsules of different dosages will be indistinguishable. Then followed by 4 weeks of placebo (placebo capsule will be matched with LDN capsule, microcrystalline cellulose filler, 1 capsule daily).
Group B will receive 4 weeks of placebo (placebo capsule will be matched with LDN capsule, microcrystalline cellulose filler, 1 capsule daily). Then followed by active drug (Naltrexone 1 capsule by mouth daily, 1.5mg x1 week, 3mg x1 week, and 4.5 mg x6 weeks) for the last 8 weeks. Capsules of different dosages will be indistinguishable.