Recruiting

Low Dose Naltrexone

Sponsor:

Emory University

Code:

NCT05537935

Conditions

Human Immunodeficiency Virus

Chronic Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Low Dose Naltrexone

Study Details

Brief summary:

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

Human Immunodeficiency Virus

Chronic Neuropathic Pain

Study ID

NCT05537935

Start date

Apr 28, 2023

Status verified date

Mar, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

Once a potential subject has been identified they may be contacted with information about the study in advance of their appointment in order to allow time for them to consider the study. A qualifying pain score will be confirmed with the subject prior to initiating consent. This may occur up to 30 days before the baseline, treatment visit, but inclusion/exclusion criteria will be re-confirmed prior to initiating study treatment. Patients may also be approached during a clinic visit.

Should a patient decline participation in the treatment plan, they will be invited to participate in a control group. They will be invited to complete the PROMIS questionnaire every 4 weeks, and the NPRS pain assessment every week from Baseline through week 12. These participants will receive follow up phone calls to confirm completion of these assessments weekly and will not have any in-person visits.

experimental: Low Dose Naloxone (LDN)

Once a potential subject has been identified they may be contacted with information about the study in advance of their appointment in order to allow time for them to consider the study. A qualifying pain score will be confirmed with the subject prior to initiating consent. This may occur up to 30 days before the baseline, treatment visit, but inclusion/exclusion criteria will be re-confirmed prior to initiating study treatment. Patients may also be approached during a clinic visit.

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 four-week supply of study medication. LDN will be given as a daytime dose.

Interventions

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 measure

  • Changes in Numerical Pain Score [ Time Frame: Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 12 ]

Central Contacts and Locations

Central contacts

Anne M McKenzie-Brown, MD

404-686-2410amckenz@emory.edu

Locations

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Brian Bobzien, MD

404-616-5078brian.patrick.bobzien@emory.edu

Emory Midtown Hospital

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Kimberly A Workowski, MD

404-686-7893kworkow@emory.edu

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Anne M McKenzie-Brown, MD

404-686-2410amckenz@emory.edu

More Information

Sponsor

Emory University

Last update posted

Apr 9, 2026

Last verified

Mar, 2026

Keywords

  • Low dose Naltrexone
  • Naltrexone
  • Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-04-09.