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New treatment option for Painful Diabetic Neuropathy
Official title Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy
ClinicalTrials.gov ID: NCT04678895
What this study is testing
What is Naltrexone?
Naltrexone is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for painful diabetic neuropathy.
Also referred to as LDN.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- people capable of giving informed consent
- Greater than 18 years of age
You likely can't join if
- 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
- Current opioid therapy or on opioid therapy within the past 1 month
See the full eligibility criteria
- 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
- people capable of giving informed consent
- Greater than 18 years of age
- Stable on all current non-opioid pain medication for at least 1 month
- English as primary language
- 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
- Current opioid therapy or on opioid therapy within the past 1 month
The study team makes the final eligibility decision.
Where it's taking place
- Lebanon, New Hampshire, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lebanon, New Hampshire, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.