Low Dose Naltrexone for Pain in Patients With HIV
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEmory University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Use of oral, injected, or implanted hormonal methods of contraception or;
Trial design
Design model
Parallel
Treatments tested in this trial
Low Dose Naltrexone
DrugParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Low Dose Naloxone (LDN)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in Numerical Pain Score
The study team will give participants a link to the online PROMIS questionnaire that includes a numerical pain rating scale (NPRS) to complete using an iPad or computer and will verbally ask questions to establish baseline information required for the study. If they have no computer access, they will be given a hard copy of the PROMIS questionnaire and NPRS to complete for future visits. The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). Changes in pain scores, measured on the numerical pain score (NPS) on the Pain Intensity section of the PROMIS-29 Profile v2.0. This will be measured weekly during the 12-week study period.
Time frame
Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 12Secondary outcomes
1
Changes in PROMIS pain Score
The study team will give participants the PROMIS questionnaire to complete using an iPad or computer, or a paper form, and will verbally ask questions to establish baseline information required for the study. If they have no computer access, they will be given a hard copy of the PROMIS questionnaire to complete for future visits. Changes in the overall score of the PROMIS-29 Profile v2.0 questionnaire collected at baseline, 4, 8, and 12 weeks will be assessed. The participants' answers to PROMIS-29 are scored from 1-5. The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score. PROMIS assessments use an Item Response Theory (IRT) based score called "Expected A Posteriori" or EAP scores, which are then transformed onto a final T-score metric. The scores are mapped so that the values follow a normal distribution with a population mean T-score of 50 and a standard deviation of 10.
Time frame
Study weeks 0, week 4, week 8 and week 122
Changes in Average pain Score
The study team will give participants a link to the online PROMIS questionnaire that includes a numerical pain rating scale (NPRS) to complete using an iPad or computer and will verbally ask questions to establish baseline information required for the study. If they have no computer access, they will be given a hard copy of the PROMIS questionnaire and NPRS to complete for future visits. The study team will compare the average weekly pain scores of the study group with the control group.
Time frame
Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 123
Changes in IL-1 levels
Blood will be drawn by phlebotomy services according to institutional practice. Samples for will be sent to the Emory Medical Laboratory at EUH or Emory University Hospital Midtown (EUHM) for processing and analysis. Serum cytokines values will be measured at the 12-week visit and will be compared to baseline visit values.
Time frame
Study week 0 and week 124
Changes in IL-18 levels
Blood will be drawn by phlebotomy services according to institutional practice. Samples for will be sent to the Emory Medical Laboratory at EUH or Emory University Hospital Midtown (EUHM) for processing and analysis. Serum cytokines values will be measured at the 12-week visit and will be compared to baseline visit values.
Time frame
Study week 0 and week 12Sponsors and contacts
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Source ClinicalTrials.gov