Actively Recruiting
Low Dose Naltrexone for Chronic Neuropathic Pain in Adults With HIV Infection A Prospective, Pragmatic, Open Label Clinical Trial
Led by Emory University · Updated on 2026-04-09
60
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of low-dose naltrexone (LDN) to treat chronic neuropathic pain in adults living with HIV who have some level of viral control but still experience pain. The study aims to explore whether LDN, an opioid antagonist used at lower doses as an immune modulator, can reduce pain and improve immune markers such as CD4 count. This study addresses the need for safer, more effective pain treatments in this population, given the limitations and side effects of chronic opioid use. Participants will either receive low-dose naltrexone starting at 3 mg daily for one week, increasing to 4 mg daily if tolerated, or be part of a control group without intervention. The medication is taken orally during the day to minimize side effects like sleep disturbances. The study lasts 12 weeks, during which participants' pain scores and inflammatory markers are regularly assessed. Control group members will provide pain and symptom data remotely without in-person visits. During the study, participants will have their pain levels measured weekly using numerical rating scales and questionnaires, while blood tests will monitor inflammation and immune system markers at the start and end of the 12-week period. The study also tracks CD4 counts as part of routine care. Researchers will review changes in pain intensity, symptom scores, and biological markers to evaluate LDN's impact. Participants are followed closely through clinic visits or phone calls, and their safety and symptom changes are monitored throughout the study.
CONDITIONS
Brief Title
Low Dose Naltrexone for Pain in Patients With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Diagnosed HIV infection with viral load below 1000 copies/ml for the past 12 months
- Diagnosis of neuropathic pain using a neuropathic pain screening tool
- Average pain score greater than 4 out of 10 lasting more than 3 months
- Able to give informed consent and willing to follow study requirements
- Fluent in English
You will not qualify if you...
- Allergy to naltrexone (not applicable for control group)
- Current use of any opioids within 10 days before study start (not applicable for control group)
- Pregnant women
- Nursing mothers and women of childbearing potential not using highly effective contraception (not applicable for control group)
- Bipolar disorder, schizophrenia, poorly controlled anxiety or depression
- Diagnosis of liver disease such as cirrhosis
- Chronic kidney disease or acute kidney injury with GFR less than 45 at baseline
- Acute viral hepatitis A, B, or C
- Positive test or diagnosis of COVID-19 or other viral illness within past 10 days
- Known or suspected long-term COVID
- Active drug or alcohol use disorder
- Anticipated need for opioid therapy during the study
- Transportation issues interfering with study visits (not applicable for control group)
- Adults unable to consent
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants will take low-dose naltrexone orally each day, starting with 3 mg daily for one week, then increasing to 4 mg daily if tolerated, for 12 weeks to help manage neuropathic pain.
1 baseline visit and weekly assessments for 12 weeks
Trial Site Locations
Total: 3 locations
1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Actively Recruiting
2
Emory Midtown Hospital
Atlanta, Georgia, United States, 30308
Actively Recruiting
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
A
Anne M McKenzie-Brown, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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