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Low Dose Naltrexone for Pain in Patients With HIV

StatusRecruiting
PhasePhase 4
Started2023-04-28
View on ClinicalTrials.gov ↗

Amendment history

2026-04-06
Study Identification, Study Status, Eligibility v9
Primary completion date2025-12-31→2027-06-30
Completion date2026-12→2027-06-30
Eligibility criteria-4 characters
Inclusion Criteria: Age 18-75, male and female HIV infection with a viral load of < 1000 copies/ml for the past six12 months. (That is the viral load below which, according to t [...] icians and Gynecologists (ACOG) Committee Opinion, there is notno thought to beof a significant risk of HIV transmission from the mother to t [...] or disease involving the somatosensory nervous system, e.g., painful neuropathy, radicular pain, complex regional pain sy [...] intrauterine system (IUS); Barrier methods of contraception;: condom or occlusive cap (diaphragm or cervical /vault caps) [...]
2025-07-14
Study Status, Eligibility v8
Primary completion date2025-06→2025-12-31
Completion date2025-06→2026-12
Eligibility criteriarevised
[...] chronic kidney disease or acute kidney injury and/or a GFR <6045 at baseline Acute viral hepatitis A, B, C Patients who self [...]
2025-05-01
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v7
Eligibility criteriarevised
Inclusion Criteria: Age 18-6575, 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 Coll [...] g > 3 months (chronic pain) Capable of informed consent and willingnesswilling to comply with the study requirements Fluent English-speaki [...]
Secondary endpointsdetails revised at 1 of 7 entries
Study description+7 characters
[...] Many people living with HIV/AIDS have untreated chronic pain, which negatively affects their quality of life. Neuropathic [...] are more consistently known for a multitude of side effects, than effective long-term pain relief. Lesser-known side eff [...] (LDN) is an off-label use of naltrexone with some evidence that it may help chronic pain, such as fibromyalgia and some types of neuropathic (nerve) [...] much lower dose of naltrexone. It has to be compounded to 1/10th10 of the usual dose to be repurposed to treat pain. In this stud [...]
2024-04-29
Suspended→Recruiting Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v6
Trial statusSuspended→Recruiting
Reason stoppedRecruitment has been temporarily paused for IRB review→not stated
Primary completion date2024-03→2025-06
Completion date2024-03→2025-06
Eligibility criteria+59 characters
Inclusion Criteria: Age 18-65, male and female HIV infection with a viral load of < 1000 copies/ml for the past six months. (Th [...] th vaginal delivery. This was thought to be a reasonable cut-off for inclusion in this study.) Diagnosis of neuropathic p [...] pathy, 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 [...] ingness to comply with the study requirements Fluent English-speaking Exclusion Criteria: A [...] [...]
Secondary endpoints9 to 7 entries
Changes in IL-6PROMIS levelspain Score Changes in IL-8Average levelspain Score Changes in CRPMet-Enkephalin Levels Changes in TNF-α Levels Changes in Met-Encephalin Levels Changes in DC4CD4 counts
Primary endpoints3 to 1 entries
Changes in Average pain Score Changes in PROMIS pain Score
Study description-11 characters
[...] ent and maintenance of HIV than their Caucasian counterparts, and are thus less likely to have adequate suppression of th [...] m pain relief. Lesser-known side effects of chronic opioids includesinclude suppressing, or dampening, the immune system, making opioid [...] pathic pain have undesirable side effects. Naltrexone is FDA-approved for addiction and is not used to treat a medical di [...] altrexone. It has to be compounded to 1/10th the usual dose in order to be repurposed to treat pain. In this study, 40 adult pati [...]
Study sitesdetails revised at 3 of 3 sites
2023-06-09
Recruiting→Suspended Study Status, Contacts/Locations v5
Trial statusRecruiting→Suspended
Reason stoppednot stated→Recruitment has been temporarily paused for IRB review
Study sitesdetails revised at 3 of 3 sites
Show 4 earlier versions
2023-05-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-04→confirmed 2023-04-28
Study sitesdetails revised at 3 of 3 sites
2023-03-21
Study Status v3
Start date2023-03-15→2023-04
2023-02-17
Study Status v2
Start date2023-01-15→2023-03-15
2022-12-15
Study Status v1
Primary completion date2024-02→2024-03
Completion date2024-02→2024-03
Start date2022-11→2023-01-15
2022-09-09
Original filing
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.
Trial Details
NCT Number NCT05537935
Lead Sponsor Emory University
Conditions Human Immunodeficiency Virus, Chronic Neuropathic Pain
Enrollment 60 participants
Start Date 2023-04-28
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-09