Low Dose Naltrexone for Pain in Patients With HIV

• Status: Not yet recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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 of a drug used for substance use disorder to a medication with the potential to treat pain and improve symptoms for PLWHA.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

• Age 18-65, male and female

• HIV infection with viral load of < 1000 copies/ml for the past six months. (That is viral load below which, according to the 2018 American College of Obstetricians and Gynecologists (ACOG) Committee Opinion, there is not thought to be 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.)

• Pain score > 4/10 on average on the NPRS lasting > 3 months (chronic pain)

• Capable of informed consent and willingness to comply with the study requirements

• Fluent English speaking

Exclusion Criteria:

• Allergy to naltrexone

• Current use of any opioids, excluding tramadol up to 1 week prior to the start of the study

• Pregnant women, nursing mothers and women of childbearing potential not using contraception known to be highly effective. Highly effective contraception methods include combination of any two of the following during the 12 week study period: Low Dose Naltrexone for the Treatment of Chronic Neuropathic Pain in Patients with Human Immunodeficiency Virus (HIV), a Prospective, Pragmatic, Open Label Clinical Trial

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

• End-stage liver disease, e.g. cirrhosis

• End-stage kidney disease, e.g. requiring chronic peritoneal or hemodialysis

• Acute viral hepatitis A, B, C

• 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

• Individuals who are not yet adults (infants, children, teenagers)

• Prisoners

• Cognitively impaired or Individuals with Impaired Decision-Making Capacity

• Individuals who are not able to clearly understand English