NCT05537935 · Emory University
Low Dose Naltrexone for Pain in Patients With HIV
What this study 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.
View original scientific description
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.
Interventions
DRUG
Low 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.
Primary outcome measures
Changes in Numerical Pain Score
Time frame: Study 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- Use of oral, injected, or implanted hormonal methods of contraception or;
- Placement of an intrauterine device (IUD) or intrauterine system (IUS);
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical /vault caps) with spermicidal foam/gel/film/cream/vaginal suppository;
- Total abstinence;
- 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
Where
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations