Low Dose Naltrexone for Pain in Patients With HIV

This study is looking at whether a medication called Low Dose Naltrexone (LDN) can help reduce chronic (long-lasting) pain in people living with Human Immunodeficiency Virus (HIV). Many people with HIV experience chronic pain, especially nerve pain, which can be hard to treat and is often managed with opioid medications that have unwanted side effects. LDN is a much lower dose of naltrexone, a drug approved for addiction treatment. Researchers believe LDN might help by affecting the immune system. You may be able to join if you are 18-75 years old, have HIV, and your viral load (the amount of HIV in your blood) has been below 1000 copies/ml for the past 12 months. The study will measure changes in your pain levels over 12 weeks to see if LDN is effective. The current recruitment status is unclear, and the study plans to enroll 60 participants.

Study design: This interventional study plans to enroll 60 participants. It is not specified if it is randomized or blinded.
What's involved: Participants will take 3mg of Low Dose Naltrexone daily for one week, then increase to 4mg daily if tolerated. Pain levels will be measured at various points over 12 weeks.
Compensation: Not stated in the trial record.
Follow-up: Your pain levels will be monitored for 12 weeks after starting the study medication.

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Low Dose Naltrexone for Pain in Patients With HIV

Recruiting

PHASE4Ages 18–75InterventionalTreatment

Emory University

~60 participants

Updated 2026-04-09 on ClinicalTrials.gov

What's tested:Low Dose Naltrexone

At a glance

Recruiting sites

3 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Changes in Numerical Pain Score

Measured over Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 12

Conditions

Human Immunodeficiency Virus

Chronic Neuropathic Pain

Where it's being run

3 sites across 1 states

Georgia3

Study leadership

Anne M McKenzie-Brown, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Anne M McKenzie-Brown, MD

[email protected]

404-686-2410

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18-75, male and female

HIV infection with a viral load of \< 1000 copies/ml for the past 12 months. (That is the viral load below which, according to the 2018 American College of Obstetricians and Gynecologists (ACOG) Committee Opinion, there is no thought of a significant risk of HIV transmission from the mother to the fetus with vaginal delivery. This was thought to be a reasonable cut-off for inclusion in this study.)

Diagnosis of neuropathic pain (pain that is associated with a lesion or disease involving the somatosensory nervous system, e.g., painful neuropathy, radicular pain, complex regional pain syndrome, nerve-related pain following spine surgery, etc.) using the neuropathic pain screening tool, painDETECT17, as part of the neuropathic pain screen.

Pain score \> 4/10 on average on the NPRS lasting \> 3 months (chronic pain)

Capable of informed consent and willing to comply with the study requirements

Fluent English-speaking

Exclusion

Allergy to naltrexone (not applicable to the control group)

Current use of any opioids, up to 10 days before the start of the study (not applicable to the control group)

Pregnant women

Nursing mothers and women of childbearing potential not using contraception known to be highly effective (not applicable for the control group). Highly effective contraception methods include a combination of any two of the following during the 12-week study period:

Bipolar disorder, schizophrenia, poorly controlled anxiety or depression

Diagnosis of liver disease, e.g. cirrhosis

Current diagnosis of either chronic kidney disease or acute kidney injury and/or a GFR \<45 at baseline

Acute viral hepatitis A, B, C

Patients who self-report as having tested positive for COVID-19 or have been diagnosed with another viral illness within the past ten days.

Patients with a known or suspected diagnosis of long-term COVID

Active drug or alcohol use disorder

People who may require opioid therapy during the duration of the study, e.g. upcoming surgery

Transportation issues interfering with return study visits (NA for the control group)

Adults unable to consent

Prisoners

What this trial measures

Changes in Numerical Pain ScoreStudy weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 12
The study team will give participants a link to the online PROMIS questionnaire that includes a numerical pain rating scale (NPRS) to complete using an iPad or computer and will verbally ask questions to establish baseline information required for the study. If they have no computer access, they will be given a hard copy of the PROMIS questionnaire and NPRS to complete for future visits. The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). Changes in pain scores, measured on the numerical pain score (NPS) on the Pain Intensity section of the PROMIS-29 Profile v2.0. This will be measured weekly during the 12-week study period.

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