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 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT04050735
Eligibility Criteria:
General Inclusion Criteria:
1. 21-60 years old;
2. Able to speak and read English at least at 8th grade level;
3. Alcohol use ≥.60 g/kg at least once in past year. In standard drinks, this amount translates to 1.9-3.0 drinks for an average-weight female and 2.4-3.9 drinks for an average-weight male.
4. Body mass index of 18.5-34.9 kg/m2;
5. Lab tests obtained in past year showing no evidence of acute/chronic Hepatitis B or C infection;
6. HIV-1 serostatus (positive or negative, depending on group) confirmed by standard clinical testing;
7. Able to consume soy and nuts safely (in order to consume the standardized meal).
General Exclusion Criteria:
1. History of heavy drinking on a weekly or more frequent basis, with heavy drinking defined per NIAAA guidelines (≥4 drinks for women, ≥5 drinks for men on a given day), in the past two years;
2. More than five heavy drinking episodes in past 90 days;
3. Seeking or receiving treatment for alcohol/drug use, with exception of smoking cessation treatment;
4. Antibiotic use in past 1 month;
5. Daily use of non-steroidal anti-inflammatory drugs, which are known to increase gut permeability;
6. Disorder of the lower GI tract (e.g., inflammatory bowel disease, ulcerative colitis);
7. Positive urine test for amphetamine, cocaine, methamphetamine, opioids, or benzodiazepines (cannabis use will be assessed but is not an exclusion criterion);
8. Positive screening for past 12-month drug use disorder, indicated by Drug Abuse Screening Test-10 score \>2;
9. Current major psychiatric disorder (current major depressive episode, bipolar disorder, psychotic disorder);
10. History of fainting, weakness, infection, excessive bruising, or extreme distress from blood draw;
11. Safety contraindication for MRI (e.g., metal implant); Note: copper intrauterine devices (IUDs) continue to be excluded due to Brown MRI research facility regulations but other non-metal IUDs are allowed;
12. Head trauma with loss of consciousness \>10 min;
13. Inability to abstain from nicotine for 8 hours in-session;
14. For cannabis users: inability to abstain for 48 hours prior to study;
15. Pregnant, breastfeeding, or not using effective birth control;
16. Any other clinical condition or therapy that, in the physician's opinion, would make subject unsuitable for study or unable to comply with dosing requirement.
HIV-Specific Inclusion Criteria:
1. On antiretroviral therapy (ART) for ≥6 mos;
2. Labs in past 6 mos showing viral load \<100 copies/mL, hemoglobin ≥10.0 g/dL, neutrophil count ≥1,000 cells/μL, and platelet count ≥150,000/μL;
3. No active AIDS diagnosis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT04050735
Study Brief:
Protocol Section:
NCT04050735