Low Dose Naltrexone for Pain in Patients With HIV

Launched by EMORY UNIVERSITY · Sep 9, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Low Dose Naltrexone (LDN) on chronic pain in people living with HIV. Chronic pain is a common issue for these patients, and current treatments often involve strong opioids, which can lead to unwanted side effects. The hope is that LDN, which is typically used to help people with substance use disorders, can help reduce pain and improve overall health by potentially boosting the immune system.

To participate in this study, individuals need to be between 18 and 65 years old, have HIV with a controlled viral load (meaning there is a low amount of the virus in their blood), and experience chronic neuropathic pain that has lasted for more than three months. Participants will receive LDN and will be monitored for any improvements in their pain and immune system health. It’s important to note that certain medical conditions and treatments may exclude someone from participating. If you or someone you know is dealing with chronic pain related to HIV, this trial could provide an opportunity to explore a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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 \<60 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