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Opioid Antagonist

Low-Dose Naltrexone for Diabetic Neuropathy

Phase 2
Recruiting
Led By Bruce M Vrooman, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Painful Diabetic Neuropathy (PDN) for >6 months
Greater than 18 years of age
Must not have
Presence of known causes of lower extremity neuropathic pain not attributed to PDN
Current opioid therapy or on opioid therapy within the past 1 month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment through week 12
Awards & highlights

Summary

This trial is testing Low-Dose Naltrexone (LDN) to see if it can help people with diabetes who have painful neuropathy in their legs and feet. LDN aims to reduce pain by enhancing the body's natural pain relief and decreasing inflammation. The study hopes to find a safer, non-opioid alternative for managing this difficult-to-treat pain.

Who is the study for?
Adults over 18 with painful diabetic neuropathy for more than 6 months, who've tried and failed at least one standard treatment like Gabapentin or duloxetine. Participants must be stable on current non-opioid pain meds for a month, speak English, and can't have other causes of lower leg pain or any substance use disorders.
What is being tested?
The trial is testing Low-Dose Naltrexone (LDN) against a placebo to see if it helps with the pain from diabetic neuropathy without using opioids. LDN works by boosting natural pain relief in the body and reducing inflammation.
What are the potential side effects?
Low-Dose Naltrexone is generally safe with minimal side effects reported. However, some may experience mild issues such as nausea, headache, sleep disturbances or vivid dreams.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with painful diabetic neuropathy for over 6 months.
Select...
I am older than 18 years.
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My leg pain is not caused by any known condition.
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I have tried at least one standard treatment for nerve pain without success.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have nerve pain in my legs not caused by diabetic nerve damage.
Select...
I am currently using opioids or have used them in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment through week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment through week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain
Change in Pain Disability Index
Secondary study objectives
Ratio of Pain Catastrophizing Scores Compared to Change in Numeric Rating Scale
Ratio of Pain Catastrophizing Scores Compared to Change in Pain Disability Index
Ratio of Pre-treatment Expectations Compared to Change in Numeric Rating Scale
+1 more

Side effects data

From 2011 Phase 4 trial • 165 Patients • NCT00006489
24%
Nausea
12%
Headache
12%
Cold
10%
Dry Mouth
10%
Fatigue
7%
Gastrointestinal Issues
7%
Muscle Aches
7%
Vomiting
7%
Serious Suicidal Ideation
5%
Diarrhea
5%
Constipation
5%
Stomach Virus
5%
Changes to Vision
5%
Loose Stool
5%
Increased Irritability
5%
Sedation
5%
Stomach Pain
5%
Increased Bowel Movements
2%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naltrexone + Supportive Counseling
Naltrexone + CBT (Prolonged Exposure Therapy)
Placebo + CBT (Prolonged Exposure Therapy)
Placebo + Supportive Counseling

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group B, Placebo, Then Low-Dose NaltrexoneExperimental Treatment2 Interventions
Group B will receive 4 weeks of placebo (placebo capsule will be matched with LDN capsule, microcrystalline cellulose filler, 1 capsule daily). Then followed by active drug (Naltrexone 1 capsule by mouth daily, 1.5mg x1 week, 3mg x1 week, and 4.5 mg x6 weeks) for the last 8 weeks. Capsules of different dosages will be indistinguishable.
Group II: Group A, Low-Dose Naltrexone, Then PlaceboExperimental Treatment2 Interventions
Group A will receive active drug (Naltrexone 1 capsule by mouth daily, 1.5mg x1 week, 3mg x1 week, and 4.5 mg x6 weeks) for the first 8 weeks. Capsules of different dosages will be indistinguishable. Then followed by 4 weeks of placebo (placebo capsule will be matched with LDN capsule, microcrystalline cellulose filler, 1 capsule daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
2005
Completed Phase 4
~2420
Placebo
1995
Completed Phase 3
~2670

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for diabetic neuropathy include gabapentinoids (e.g., gabapentin, pregabalin), which modulate calcium channels to reduce nerve excitability, and antidepressants (e.g., amitriptyline, duloxetine), which inhibit the reuptake of serotonin and norepinephrine to enhance pain inhibition pathways. Low-Dose Naltrexone (LDN) works by enhancing the body's natural pain relief mechanisms and reducing inflammation through microglia modulation. These mechanisms are crucial for diabetic neuropathy patients as they address both the pain and the underlying inflammatory processes, potentially improving pain management and quality of life.

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
536 Previous Clinical Trials
2,539,652 Total Patients Enrolled
Reuel J Measom, MDStudy DirectorDartmouth-Hitchcock Medical Center
Bruce M Vrooman, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center

Media Library

Naltrexone (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04678895 — Phase 2
~7 spots leftby Sep 2025
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