Using low dose naltrexone to treat pain in HIV patients

Low Dose Naltrexone (LDN) for the Treatment of Chronic Neuropathic Pain in Patients With Human Immunodeficiency Virus (HIV), a Prospective, Pragmatic, Open Label Clinical Trial

This study is testing whether low dose naltrexone can help relieve chronic pain in people living with HIV.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Emory University (Academic / other)
• Locations: 3 sites (Atlanta, Georgia and 2 other locations)
• Trial ID: NCT05537935 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of low dose naltrexone (LDN) on chronic neuropathic pain in patients living with HIV. Given the challenges of treating chronic pain in this population, which often relies on opioids with significant side effects, LDN offers a potential alternative therapy. The study will enroll participants who have a stable HIV viral load and a diagnosis of neuropathic pain, assessing pain relief and overall quality of life. The approach aims to repurpose an existing medication to improve pain management in a vulnerable patient group.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with HIV and chronic neuropathic pain who have a stable viral load.

Not a fit: Patients with uncontrolled HIV or those not experiencing chronic neuropathic pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for managing chronic pain in patients with HIV.

How similar studies have performed: While there are limited clinical trials specifically examining LDN for pain relief, there are numerous case reports suggesting its efficacy, indicating a promising but relatively novel approach.

Eligibility criteria

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

Where this trial is running

Atlanta, Georgia and 2 other locations

• Grady Memorial Hospital — Atlanta, Georgia, United States (Recruiting)
• Emory Midtown Hospital — Atlanta, Georgia, United States (Recruiting)
• Emory University Hospital — Atlanta, Georgia, United States (Recruiting)

Study contacts

• Principal investigator: Anne M McKenzie-Brown, MD — Emory University
• Study coordinator: Anne M McKenzie-Brown, MD

Conditions Human Immunodeficiency Virus; Chronic Neuropathic Pain; Low dose Naltrexone; Naltrexone; Pain