Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy, a Small, Randomized, Double-blind, Placebo-controlled Crossover Trial
Dartmouth-Hitchcock Medical Center
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.
Description
The study design is a randomized, double-blind, placebo-controlled, crossover trial. The subjects and investigators will remain blinded for the duration of the study. Subjects will be randomized under the direction of investigational pharmacy and will be randomized in groups of 6 subjects with 3 being assigned to Group A and the other 3 being assigned to Group B. The randomization information will remain under the purview of Investigational Pharmacy until the conclusion of the study, who will be unblinded during the study for management of appropriate medication dispersal following randomizati…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 disor…
Interventions
- DrugNaltrexone
Capsule with doses of 1.5mg, 3mg, and 4.5 mg to allow for drug titration. Capsules of different dosages will be indistinguishable to allow for maintenance of blinding.
- DrugPlacebo
Naltrexone matched placebo capsule.
Location
- Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire