RecruitingPhase 4NCT05537935

Low Dose Naltrexone for Pain in Patients With HIV

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

Sponsor

Emory University

Enrollment

60 participants

Start Date

Apr 28, 2023

Study Type

INTERVENTIONAL

Conditions

Human Immunodeficiency Virus Chronic Neuropathic Pain

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

Age 18-75, male and female
HIV infection with a viral load of \< 1000 copies/ml for the past six months. (That is the 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.) 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 Criteria20

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
Prisoners

Interventions

DRUGLow 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.