RECRUITING

Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-12-22
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04678895

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of Painful Diabetic Neuropathy (PDN) for \>6 months
  2. 2. Has failed at least one prior standard treatment for PDN (Gabapentin, duloxetine, etc)
  3. 3. No other known causes of lower extremity neuropathic pain
  4. 4. Subjects capable of giving informed consent
  5. 5. Greater than 18 years of age
  6. 6. Stable on all current non-opioid pain medication for at least 1 month
  7. 7. English as primary language
  1. 1. Known allergy to naltrexone or naloxone
  2. 2. Presence of known causes of lower extremity neuropathic pain not attributed to PDN
  3. 3. Active substance use disorder or alcohol use disorder as defined by DSM-V (The Diagnostic and Statistical Manual of Mental Disorders)
  4. 4. Current treatment for substance use disorder or alcohol use disorder
  5. 5. Current opioid therapy or on opioid therapy within the past 1 month

Contacts and Locations

Study Contact

Sean G Dabney
CONTACT
603-653-3337
Sean.G.Dabney@hitchcock.org

Principal Investigator

Bruce M Vrooman, MD
PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center

Study Locations (Sites)

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
United States

Collaborators and Investigators

Sponsor: Dartmouth-Hitchcock Medical Center

  • Bruce M Vrooman, MD, PRINCIPAL_INVESTIGATOR, Dartmouth-Hitchcock Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-22
Study Completion Date2025-09

Study Record Updates

Study Start Date2020-12-22
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Low-Dose Naltrexone
  • Painful Diabetic Neuropathy

Additional Relevant MeSH Terms

  • Painful Diabetic Neuropathy