Low-Dose Naltrexone for Painful Diabetic Neuropathy

This study is investigating if low-dose naltrexone (LDN) can help reduce pain for people with painful diabetic neuropathy (nerve damage caused by diabetes). You might be able to join if you are over 18, have had painful diabetic neuropathy for more than six months, and have not found relief from at least one other standard treatment. The study will compare naltrexone to a placebo (an inactive pill) to see if it improves your pain and how much it affects your daily activities. The study is currently unclear about its recruitment status and plans to enroll 35 participants.

Study design
This is a randomized, double-blind, placebo-controlled, crossover study. This means you will be randomly assigned to receive either naltrexone or a placebo first, and then switch to the other treatment, without you or your doctors knowing which you are taking at any given time.
What's involved
You will receive either naltrexone or a placebo for 8 weeks and 4 weeks, respectively, with no break in between. The study measures changes in your pain and disability from when you start until week 12.
Compensation
Not stated in the trial record.
Follow-up
Your pain and disability will be measured from when you enroll through week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04678895

Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy

Recruiting
PHASE2Ages 18+InterventionalTreatment
Dartmouth-Hitchcock Medical Center
~35 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:NaltrexonePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pain Disability Index
Measured over Enrollment through week 12
+1 more outcome measured
Painful Diabetic Neuropathy
1 sites across 1 states
New Hampshire1
  • Bruce M Vrooman, MD · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center

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  • Change in Pain Disability IndexEnrollment through week 12

    Pain Disability index (PDI) Score measures the degree to which pain interferes with activities. Every item ranges from 0 (no interference) to 10 (total interference). The total PDI score can range from 0 to 70, a higher score indicating more interference with functioning across a range of activities.

  • Change in Numeric Rating Scale for PainEnrollment through week 12

    Percent Change in Numerical Rating Scale (NRS) Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment. NRS is scored between 1-10 with 1 being no pain and 10 being the worst pain one can experience.