Using Low-Dose Naltrexone to Treat Painful Diabetic Neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• High-frequency spinal cord stimulation for leg pain from diabetic neuropathy and peripheral artery disease

  This study will test whether high-frequency spinal cord stimulation can reduce walking-related leg pain in people with painful diabetic neuropathy and peripheral arterial disease who responded to a temporary SCS trial.

  Recruiting University of Nebraska · Omaha, Nebraska · NCT06480786

• Using a smartphone app to track pain and mood changes

  This study is testing a smartphone app to track pain and mood changes in people with chronic pain and healthy individuals to see how these factors affect pain over time.

  Recruiting Brown University · Providence, Rhode Island · NCT05754190

• Peripheral nerve block for painful diabetic neuropathy

  This study is testing if a nerve block can help adults with painful diabetic neuropathy feel less pain without stopping their regular medications.

  Recruiting University of Aarhus · Aarhus N, Jutland · NCT04699734

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.