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Could a tiny dose of naltrexone ease HIV nerve pain without opioids?

NCT ID NCT05537935

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Emory Midtown Hospital

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Grady Memorial Hospital

    RECRUITING

    Atlanta, Georgia, 30303, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.