Status:
RECRUITING
Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 an...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04678895
Start Date
December 22 2020
End Date
September 1 2025
Last Update
April 17 2025
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766