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Alcohol's effect on brain during HIV risk decisions revealed

NCT ID NCT04360018

Knowledge-focused Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 11 times

Summary

This study looks at how drinking alcohol changes the way people make decisions about risky sexual behavior, which could lead to HIV. Twenty healthy adults aged 21-65 will have two visits: one where they drink alcohol and one where they drink a placebo. During brain scans, they will view pictures and make choices about sex and condom use. The goal is to understand the brain processes behind risky decisions when under the influence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
alcohol beverage
What this could lead to
If successful, this study could help explain why people make riskier sexual choices after drinking, potentially guiding future prevention efforts.
What could go wrong
This is a small, early-phase study with only 20 participants, so results may not apply broadly. It measures brain activity in a lab setting, which may not reflect real-world behavior.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Mar 2021

Finished

Apr 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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 any language other than English.

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Conditions

The condition(s) this trial relates to.

Alcohol Drinking Alcoholic Intoxication Binge-Eating Disorder Risk-Taking

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol consumption

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.