Human Immunodeficiency Virus study: Low Dose Naltrexone
Official title Low Dose Naltrexone for Pain in Patients With HIV
ClinicalTrials.gov ID: NCT05537935
What this study is testing
What is Low Dose Naltrexone?
investigational oral low-dose naltrexone being studied for chronic pain in people living with HIV is designed to block opioid receptors and may modulate immune function
Also referred to as Naltrexone.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if low-dose naltrexone can reduce chronic nerve pain and improve immune health in people living with HIV.
- Who it's for
- The study is looking for adults living with HIV who have chronic nerve pain.
- What's involved
- Participants will take a low dose of naltrexone and have regular blood tests to check their immune cell counts and monitor their pain levels.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of visits required.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75, male and female
- HIV infection with a viral load of \< 1000 copies/ml for the past 12 months.
- Diagnosis of neuropathic pain (pain that is associated with a lesion or disease involving the somatosensory nervous system, e.g., painful neuropathy...
- 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
You likely can't join if
- 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;
- 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...
See the full eligibility 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...
- 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...
- 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
- 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;
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.