Low Dose Naltrexone for Pain in Patients With HIV
Human Immunodeficiency Virus, Chronic Neuropathic Pain
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring Low dose Naltrexone, Naltrexone, Pain
Eligibility Criteria
Inclusion Criteria:
- Age 18-65, male and female
- HIV infection with viral load of < 1000 copies/ml for the past six months. (That is 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.)
- Pain score > 4/10 on average on the NPRS lasting > 3 months (chronic pain)
- Capable of informed consent and willingness to comply with the study requirements
- Fluent English speaking
Exclusion Criteria:
- Allergy to naltrexone
- Current use of any opioids, excluding tramadol up to 1 week prior to the start of the study
Pregnant women, nursing mothers and women of childbearing potential not using contraception known to be highly effective. Highly effective contraception methods include combination of any two of the following during the 12 week study period: Low Dose Naltrexone for the Treatment of Chronic Neuropathic Pain in Patients with Human Immunodeficiency Virus (HIV), a Prospective, Pragmatic, Open Label Clinical Trial
- Use of oral, injected or implanted hormonal methods of contraception or;
- Placement of an intrauterine device (IUD) or intrauterine system (IUS);
- Barrier methods of contraception; condom or occlusive cap (diaphragm or cervical /vault caps) with spermicidal foam/gel/film/cream/vaginal suppository;
- Total abstinence;
- Male/female sterilization.
- Bipolar disorder, schizophrenia, poorly controlled anxiety or depression
- End-stage liver disease, e.g. cirrhosis
- End-stage kidney disease, e.g. requiring chronic peritoneal or hemodialysis
- Acute viral hepatitis A, B, C
- 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
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
- Cognitively impaired or Individuals with Impaired Decision-Making Capacity
- Individuals who are not able to clearly understand English
Sites / Locations
- Grady Memorial Hospital
- Emory Midtown Hospital
- Emory University Hospital
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control
Low Dose Naloxone (LDN)
Once a potential subject has been identified they may be contacted with information about the study in advance of their appointment in order to allow time for them to consider the study. A qualifying pain score will be confirmed with the subject prior to initiating consent. This may occur up to 30 days before the baseline, treatment visit, but inclusion/exclusion criteria will be re-confirmed prior to initiating study treatment. Patients may also be approached during a clinic visit. Should a patient decline participation in the treatment plan, they will be invited to participate in a control group. They will be invited to complete the PROMIS questionnaire every 4 weeks, and the NPRS pain assessment every week from Baseline through week 12. These participants will receive follow up phone calls to confirm completion of these assessments weekly and will not have any in-person visits.
Once a potential subject has been identified they may be contacted with information about the study in advance of their appointment in order to allow time for them to consider the study. A qualifying pain score will be confirmed with the subject prior to initiating consent. This may occur up to 30 days before the baseline, treatment visit, but inclusion/exclusion criteria will be re-confirmed prior to initiating study treatment. Patients may also be approached during a clinic visit. Subjects will be started 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 a 4 week supply of study medication. LDN will be given as a daytime dose.