💬In plain words
What the trial is, and whether it could suit you
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 specifical
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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