Low Dose Naltrexone for Pain in Patients With HIV

Inclusion Criteria:

• Age 18-75, male and female

• HIV infection with a viral load of < 1000 copies/ml for the past six months. (Thatis the viral load below which, according to the 2018 American College ofObstetricians and Gynecologists (ACOG) Committee Opinion, there is not thought to bea significant risk of HIV transmission from the mother to the fetus with vaginaldelivery. 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 diseaseinvolving 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 neuropathicpain 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 (notapplicable to the control group)

• Pregnant women

• Nursing mothers and women of childbearing potential not using contraception known tobe highly effective (not applicable for the control group). Highly effectivecontraception 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 orcervical /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 aGFR <45 at baseline

• Acute viral hepatitis A, B, C

• Patients who self-report as having tested positive for COVID-19 or have beendiagnosed 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 controlgroup)

• Adults unable to consent

• Prisoners