Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk B… (NCT04360018) | Clinical Trial Compass
CompletedPhase 1
Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors
United States20 participantsStarted 2021-03-18
Plain-language summary
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.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* 21 to 65 years old.
EXCLUSION CRITERIA for Alcohol Administration/MR scanning:
* 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.
* 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
* 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;
* HIV positive
* Currently taking PrEP
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Protected Sex Discounting MRI-Scan Portion
Timeframe: First Task
Trial details
NCT IDNCT04360018
SponsorNational Institutes of Health Clinical Center (CC)