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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment through week 12
Awards & highlights

Study Summary

This trial will explore whether Low-Dose Naltrexone is an effective pain medication for those suffering from diabetic neuropathy, a condition that causes severe pain in the legs and feet.

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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with painful diabetic neuropathy for over 6 months.
Select...
I am older than 18 years.
Select...
My leg pain is not caused by any known condition.
Select...
I have tried at least one standard treatment for nerve pain without success.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain
Change in Pain Disability Index
Secondary outcome measures
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%
Constipation
5%
Diarrhea
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

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,304 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives is this research endeavor attempting to achieve?

"Over a 12-week period, the primary outcome of this trial will be to measure Change in Pain Disability Index. Secondary outcomes include Ratio of Pre-treatment Expectations Score Compared to Change in Pain Disability Index, Ratio of Pre-treatment Expectations Compared to Change in Numeric Rating Scale, and Ratio of Pain Catastrophizing Scores Compared to Change in Pain Disability Index. All measures are scored on an individual scale ranging from 0 (no interference) - 10 (total interference), with higher numbers indicating more severe impact from pain or treatment expectations. The results for each secondary measure will be expressed as ratios depending on linearity observed within the data"

Answered by AI

In what ailments is Naltrexone commonly prescribed?

"Naltrexone is primarily prescribed to help with long-term weight management. Other possible uses of this medication include improving physical activity levels, reducing pain, and complimenting a low-calorie diet."

Answered by AI

Are there any available slots to join this medical experiment?

"Affirmative. Clinicaltrials.gov data demonstrate that this clinical trial, which was launched in December of 2020 is still actively seeking participants. The study requires 35 individuals to be recruited from one location."

Answered by AI

Have other researchers explored the potential of Naltrexone for therapeutic use?

"Currently, 46 clinical trial investigations into the efficacy of Naltrexone are ongoing with 12 in their final stage. Of these trials, 161 different medical sites across New york State are involved."

Answered by AI

How many participants have been enlisted to take part in this investigation?

"Affirmative, according to the information publicly available on clinicaltrials.gov this trial is still ongoing and accepting participants. This research was disseminated for public knowledge on December 22nd 2020 and edited most recently on August 9th 2022. Currently, 35 individuals are needed across 1 medical centre to complete the study's requirements."

Answered by AI

What potential risks could patients incur when taking Naltrexone?

"As the trial is only in Phase 2, and thus lacks efficacy data, our team at Power has tentatively assigned Naltrexone a safety rating of 2 on their three-point scale."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
New Jersey
How old are they?
18 - 65
What site did they apply to?
Dartmouth-Hitchcock Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy
Bruce M. Vrooman 2020. "Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04678895.
All > Chronic Low Back Pain > Diabetic Neuropathy
~3 spots leftby Sep 2024
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