Could a tiny dose of naltrexone ease HIV nerve pain without opioids?
NCT ID NCT05537935
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a low dose of naltrexone, a drug normally used for addiction, can safely reduce chronic nerve pain in people with HIV. About 60 adults with HIV and nerve pain will take the drug for 12 weeks and report their pain levels. The goal is to find a cheaper, non-opioid option for pain relief and possibly improve immune function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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: 1. Use of oral, injected, or implanted hormonal methods of contraception or; 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS); 3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical /vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; 4. Total abstinence; 5. Male/female sterilization. * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory Midtown Hospital
RECRUITINGAtlanta, Georgia, 30308, United States
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Emory University Hospital
RECRUITINGAtlanta, Georgia, 30322, United States
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Grady Memorial Hospital
RECRUITINGAtlanta, Georgia, 30303, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a single shot replace daily HIV pills?