Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy
Status:
Recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
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.