NCT05537935 Low Dose Naltrexone for Pain in Patients With HIV
| NCT ID | NCT05537935 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Emory University |
| Condition | Human Immunodeficiency Virus |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-04-28 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2023-04-28 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Anne M McKenzie-Brown, MD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT05537935 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Human Immunodeficiency Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05537935 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05537935 currently recruiting?
Yes, NCT05537935 is actively recruiting participants. Contact the research team at amckenz@emory.edu for enrollment information.
Where is the NCT05537935 trial being conducted?
This trial is being conducted at Atlanta, United States, Atlanta, United States, Atlanta, United States.
Who is sponsoring the NCT05537935 clinical trial?
NCT05537935 is sponsored by Emory University. The principal investigator is Anne M McKenzie-Brown, MD at Emory University. The trial plans to enroll 60 participants.