Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy
ConditionPainful Diabetic Neuropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Painful Diabetic Neuropathy (PDN) for >6 months
Has failed at least one prior standard treatment for PDN (Gabapentin, duloxetine, etc)
No other known causes of lower extremity neuropathic pain
Subjects capable of giving informed consent
Disqualifiers
Known allergy to naltrexone or naloxone
Presence of known causes of lower extremity neuropathic pain not attributed to PDN
Active substance use disorder or alcohol use disorder as defined by DSM-V (The Diagnostic and Statistical Manual of Mental Disorders)
Current treatment for substance use disorder or alcohol use disorder
Trial design
Design model
Crossover
Treatments tested in this trial
Naltrexone
DrugCapsule with doses of 1.5mg, 3mg, and 4.5 mg to allow for drug titration. Capsules of different dosages will be indistinguishable to allow for maintenance of blinding.
Placebo
DrugNaltrexone matched placebo capsule.
Treatment groups
35 Participants
are divided into 2 treatment groupsGroup A: Group A, Low-Dose Naltrexone, Then PlaceboExperimental treatment 2 interventions
Group B: Group B, Placebo, Then Low-Dose NaltrexoneExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Pain Disability Index
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.
Time frame
Enrollment through week 122
Change in Numeric Rating Scale for Pain
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.
Time frame
Enrollment through week 12Secondary outcomes
1
Ratio of Pain Catastrophizing Scores Compared to Change in Pain Disability Index
Assessment of the presence of pain catastrophizing behaviors based on the PCS and their effect in consideration of percent change with the Pain Disability Index. PCS is scored based on 13 questions with values ranging 0 to 4 for a total possible score of 52. The higher the score the more pain catastrophizing is present. 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. The result of these two measures will be expressed as a ratio of Change in PDI over PCS. If linear, we will use the ratio or an appropriate transformation as indicated by the data.
Time frame
Questionnaire will be administered on enrollment and compared to final pain score data, approximately 12 weeks.2
Ratio of Pain Catastrophizing Scores Compared to Change in Numeric Rating Scale
Assessment of the presence of pain catastrophizing behaviors based on the PCS and their effect in consideration of percent change with the NRS. PCS is scored based on 13 questions with values ranging 0 to 4 for a total possible score of 52. The higher the score the more pain catastrophizing is present. NRS is scored between 1-10 with 1 being no pain and 10 being the worst pain one can experience. The result of these two measures will be expressed as a ratio of Change in NRS over PCS. If linear, we will use the ratio or an appropriate transformation as indicated by the data.
Time frame
Questionnaire will be administered on enrollment and compared to final pain score data, approximately 12 weeks.3
Ratio of Pre-treatment Expectations Score Compared to Change in Pain Disability Index
Qualitative assessment of pre-treatment expectations, goals for treatment and confidence in the treatment based on a set of three questions. Each question will be assessed by a healthcare provider and scored between 1 to 5, 1 being low confidence towards treatment and 5 being very high confidence in treatment. Total possible score of 15. This will be compared to Change in Pain Disability Index. 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. The result of these two measures will be expressed as a ratio of Change in PDI over Pre-treatment Expectations Score. If linear, we will use the ratio or an appropriate transformation as indicated by the data.
Time frame
Questionnaire will be administered on enrollment and compared to final pain score data, approximately 12 weeks.4
Ratio of Pre-treatment Expectations Compared to Change in Numeric Rating Scale
Qualitative assessment of pre-treatment expectations, goals for treatment and confidence in the treatment based on a set of three questions. Each question will be assessed by a healthcare provider and scored between 1 to 5, 1 being low confidence towards treatment and 5 being very high confidence in treatment. Total possible score of 15. This will be compared to Numeric Rating Scale. NRS is scored between 1-10 with 1 being no pain and 10 being the worst pain one can experience. The result of these two measures will be expressed as a ratio of Change in PDI over Pre-treatment Expectations Score. If linear, we will use the ratio or an appropriate transformation as indicated by the data.
Time frame
Questionnaire will be administered on enrollment and compared to final pain score data, approximately 12 weeks.Sponsors and contacts
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Source ClinicalTrials.gov