RecruitingPhase 4NCT05537935

Low Dose Naltrexone for Pain in Patients With HIV

Low Dose Naltrexone (LDN) for the Treatment of Chronic Neuropathic Pain in Patients With Human Immunodeficiency Virus (HIV), a Prospective, Pragmatic, Open Label Clinical Trial


Sponsor

Emory University

Enrollment

60 participants

Start Date

Apr 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The increased life expectancy of Patients Living With HIV/AIDS (PLWHA) has increased the need for therapies for chronic conditions, such as chronic pain. Pain in the HIV population is often refractory and ends up being treated with chronic opioids, which are associated with adverse effects, including hyperalgesia, constipation, and risk of overdose. Naltrexone is an opioid antagonist used in the treatment of alcohol and opioid use disorders. Low Dose Naltrexone (LDN), naltrexone at a much lower dose, is thought to be an immune modulator and has been associated with an increased CD4 count in PLWHA. Repurposing this medication is relatively inexpensive and has the potential to expand access to treatment for a painful condition experienced in PLWHA. While there are many case reports on the efficacy of LDN in symptom reduction, there are only a small number of clinical trials that specifically examine pain and symptom relief. This study will include patients who are not completely virologically controlled and will monitor the CD4 counts drawn as a part of routine care. If the CD4 count improves with LDN and with reduced symptoms, this could be a significant improvement in HIV therapy for symptom control. There have been studies showing cytokine reduction in fibromyalgia patients but they did not investigate the correlation with cytokines and pain relief. This study involves repurposing a drug used for substance use disorder to a medication with the potential to treat pain and improve symptoms for PLWHA.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether low-dose naltrexone (a drug commonly used for addiction at higher doses, but being repurposed here at very small doses) can reduce nerve pain in people living with HIV. People with HIV often develop painful nerve damage (called HIV neuropathy), and current treatments are limited. **You may be eligible if:** - You are 18–75 years old - You are living with HIV and your viral load has been below 1,000 copies/mL for the past 6 months (meaning your HIV is well-controlled) - You have been diagnosed with neuropathic pain (nerve-related pain such as burning, shooting, or tingling sensations) **You may NOT be eligible if:** - Your HIV is not well controlled (viral load above 1,000) - You do not have nerve-related pain - You are currently taking opioid pain medications (naltrexone would block their effect) - You have serious liver disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow Dose Naltrexone

Participants will start with 3mg LDN orally administered daily for one week, with a planned increase to 4 mg/day beginning week two, if tolerated. They will be provided with a 4-week supply of study medication. The most common side effects are difficulty sleeping and vivid dreams, which are seen more frequently with nighttime dosing, so LDN will be given as a daytime dose.


Locations(3)

Grady Memorial Hospital

Atlanta, Georgia, United States

Emory Midtown Hospital

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT05537935


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