Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT04678895
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of Painful Diabetic Neuropathy (PDN) for \>6 months
2. Has failed at least one prior standard treatment for PDN (Gabapentin, duloxetine, etc)
3. No other known causes of lower extremity neuropathic pain
4. Subjects capable of giving informed consent
5. Greater than 18 years of age
6. Stable on all current non-opioid pain medication for at least 1 month
7. English as primary language
Exclusion Criteria:
1. Known allergy to naltrexone or naloxone
2. Presence of known causes of lower extremity neuropathic pain not attributed to PDN
3. Active substance use disorder or alcohol use disorder as defined by DSM-V (The Diagnostic and Statistical Manual of Mental Disorders)
4. Current treatment for substance use disorder or alcohol use disorder
5. Current opioid therapy or on opioid therapy within the past 1 month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04678895
Study Brief:
Protocol Section:
NCT04678895