Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT05537935

Low Dose Naltrexone for Pain in Patients With HIV

Led by Emory University · Updated on 2026-04-09

60

Participants Needed

3

Research Sites

217 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Low Dose Naltrexone for Pain in Patients With HIV

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years, male or female
  • HIV infection with a viral load below 1000 copies/ml for the past 12 months
  • Diagnosis of neuropathic pain using the neuropathic pain screening tool painDETECT
  • Average pain score greater than 4 out of 10 lasting more than 3 months
  • Able to give informed consent and willing to follow study procedures
  • Fluent in English
Not Eligible

You will not qualify if you...

  • Allergy to naltrexone
  • Use of opioids within 10 days before the study starts
  • Pregnant women
  • Nursing mothers or women of childbearing potential not using highly effective contraception
  • Bipolar disorder, schizophrenia, or poorly controlled anxiety or depression
  • 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
  • Recent COVID-19 or other viral illness within past 10 days
  • Known or suspected long-term COVID
  • Active drug or alcohol use disorder
  • Need for opioid therapy during the study period
  • Transportation issues preventing return visits
  • Adults unable to consent
  • Prisoners

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

A

Anne M McKenzie-Brown, MD

CONTACT

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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