Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT05537935
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75, 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 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.) 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05537935
Study Brief:
Protocol Section:
NCT05537935