NCT04360018CompletedPhase 1
Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors
The Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
Background: People who binge drink are more likely to have risky sexual encounters, and alcohol changes brain activity associated with reward decisions related to those behaviors. Researchers want to better understand how alcohol s effects on risky sexual behavior that might lead people to contract sexually transmitted diseases (STDs) like HIV, the virus that causes AIDS. Objective: To study how alcohol impacts decisions about engaging in risky sex. Eligibility: Healthy adults ages 21-65 without alcohol use disorder Design: Participants will have 2 study visits, 1 month apart. They will arrive and depart via taxi. They will consume alcohol at 1 visit, chosen at random. At visit 1, participants will answer questions about HIV knowledge, HIV risk behaviors, and sexual interests. They will view pictures of clothed people and pick those they might have sex with. They will think about the person s risk of having an STD and whether they would use a condom during sex. At both visits, participants will sit in a bar-like room and have 2 drinks that may contain alcohol. Then they will have magnetic resonance imaging (MRI) brain scans. For this, they will lie on a table that slides in and out of a metal tube. The scanner makes loud noises; they will get earplugs. They will complete tasks that include looking at pictures and making choices about money. At the beginning of both visits the participants will be screened with urine drug test and pregnancy test. Duiring each visit the participants breath alcohol will be measured, and they will discuss whether they feel intoxicated. Participants will get snacks and stay at the clinic for up to 6 hours after the MRIs. ...
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 22 Apr 2020
- Start date
- 18 Mar 2021
- Primary completion date
- 2 Apr 2025
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Diseases
- HIV
- NCT number
- NCT04360018
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 20
- From 18 Mar 2021 to the primary completion date, 2 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking PrEP
Other illness
- Currently seeking treatment for alcohol use disorder
- Significant history of head trauma or cranial surgery
- History of neurological disease based on self-report or neuromotor physical exam, conducted by a health care provider, that would interfere with neuroimaging research.
- Have fulfilled DSM-5 criteria for a current substance use disorder other than alcohol use disorder
- History of primary psychotic disorder
- HIV positive
Lab values
- Have liver function tests (AST, ALT, GGT, ALP) 3-times the upper limit of normal (ULN); or have Total Bilirubin above 1.5 ULN and Albumin below 3.5 g/dl;
Other
- Having less than one binge drinking episode (episodes operationally defined as having consumed four or more drinks on one day if female/ five or more if male) based on the most recent measurement within the past 90 days of screening as determined by Alcohol Timeline Follow-back.
- Female participants only (or other individuals able to get pregnant): Currently pregnant or breastfeeding
- Any flag on the MRI Safety Screening Questionnaire, unless cleared by medically responsible staff (MD/NP)
- Reported to have a facial, body, and limb flushing response to the consumption of alcohol, as determined by the Alcohol Flushing Questionnaire
- Unable to understand and communicate in English at a level sufficient to complete questionnaires and tasks that are not validated in any language other than English.
Criteria the registry did not label
- INCLUSION CRITERIA:
- 21 to 65 years old.
Age in the registry: 21 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.