Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy, a Small, Randomized, Double-blind, Placebo-controlled Crossover Trial

Who is this study for? Patients wirth Painful Diabetic Neuropathy
What treatments are being studied? Naltrexone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
Contact Information
Primary
Bruce Vrooman
bruce.m.vrooman@hitchcock.org
603-650-5000
Time Frame
Start Date: 2020-12-22
Estimated Completion Date: 2025-09
Participants
Target number of participants: 35
Treatments
Experimental: Group A, Low-Dose Naltrexone, Then Placebo
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).
Experimental: Group B, Placebo, Then Low-Dose Naltrexone
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.
Related Therapeutic Areas
Sponsors
Leads: Dartmouth-Hitchcock Medical Center

This content was sourced from clinicaltrials.gov