Using Low-Dose Naltrexone to Treat Painful Diabetic Neuropathy
Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy, a Small, Randomized, Double-blind, Placebo-controlled Crossover Trial
PHASE2 · Dartmouth-Hitchcock Medical Center · NCT04678895
This study is testing if low-dose naltrexone can help people with painful diabetic neuropathy feel less pain after other treatments haven't worked.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center (other) |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT04678895 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of low-dose naltrexone in treating painful diabetic neuropathy, a common complication of diabetes that causes severe pain in the lower legs and feet. The study employs a randomized, double-blind, placebo-controlled, crossover design, where participants will receive both the investigational drug and a placebo in alternating phases. Participants must have a diagnosis of painful diabetic neuropathy for over six months and have failed at least one standard treatment. The goal is to assess whether low-dose naltrexone can provide relief from pain while minimizing the risks associated with opioid medications.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a diagnosis of painful diabetic neuropathy for more than six months who have not responded to standard treatments.
Not a fit: Patients currently using opioids or those with other known causes of neuropathic pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer, non-opioid alternative for managing pain in diabetic neuropathy patients.
How similar studies have performed: While low-dose naltrexone has shown promise in treating other painful conditions, its use for diabetic neuropathy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 disorder or alcohol use disorder as defined by DSM-V (The Diagnostic and Statistical Manual of Mental Disorders) 4. Current treatment for substance use disorder or alcohol use disorder 5. Current opioid therapy or on opioid therapy within the past 1 month
Where this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (RECRUITING)
Study contacts
- Principal investigator: Bruce M Vrooman, MD — Dartmouth-Hitchcock Medical Center
- Study coordinator: Bruce Vrooman
- Email: bruce.m.vrooman@hitchcock.org
- Phone: 603-650-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Painful Diabetic Neuropathy, Low-Dose Naltrexone