A Phase 1 interventional study of Alcohol beverage and Placebo beverage in Alcohol Consumption, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Phase 1, Interventional, and Basic science
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.
...
Study Description:
Participants will complete baseline measures of sexual history and preferences, HIV risk and knowledge, and tasks designed to measure delay discounting of protected sex. At the first of two visits, subjects will then receive either alcohol or placebo beverages to increase their blood alcohol concentration to approximately 0.08g/dl. Then, participants will undergo functional magnetic resonance imaging while completing two protected sex discounting tasks, with and without emotional content. At a second visit, participants will receive the opposite type of beverage (alcohol or placebo). Participants will be randomly assigned to order of beverages.
Objectives:
The purpose of this protocol is to identify the neural substrates by which acute alcohol intoxication leads to an increase in HIV risk behavior during sexual encounters. An additional aim is to characterize the influence of negative and positive social context on the neural mechanism by which acute alcohol intoxication leads to an increase in HIV risk behavior during sexual encounters. This study uses a two-visit alcohol-administration procedure to examine alcohol-induced changes in brain activity during decisions about risky sex.
Endpoints:
Brain Engagement during Protected Sex Discounting (MRI-Scan Portion)
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 20 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →National Institute on Alcohol Abuse and Alcoholism (NIAAA) is the lead sponsor of 102 studies on the registry; 14 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 9 (69%) have results posted.
Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
EXCLUSION CRITERIA for Alcohol Administration/MR scanning:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
participants receive alcohol beverage
Other: Alcohol beverage
Placebo
Other: Placebo beverage
High-proof alcohol (e.g., Everclear) will be mixed with orange juice in an approximately 1:3 ratio and split evenly into two drinks. After splitting the orange juice into two cups, a small amount (approx. 6 ml) of high-proof alcohol will be floated on top of the beverage.
The final drink will have the same volume of liquid as the alcohol beverage.
Protected Sex Discounting MRI-Scan Portion
Participants will see a picture of one of the individuals selected during the pre-scan PSD procedure. They will also see two choices corresponding to 1) "Sex with this person without a condom NOW" or 2) "Sex with this person with a condom \[NOW or delay\] . Participants will have 6 seconds to press a button corresponding to their choice. Conditions of interest will vary as follows: choice difficulty- easy (probability of choosing later option \<0.33 or \>0.67) or hard (probability of choosing alternative option between 0.33 and 0.67); preference- now (probability of choosing later option \<0.5) or delay (probability of choosing later option \>0.5); sexual risk - high (individual most likely to have an STD) or low (individual least likely to have an STD); and desirability - high (individual you most want to have sex with) or low (individual you least want to have sex with).
Time frame: First Task
Sexual Sensation Seeking Scale
This will be used to assess interest in risky sexual activity. It is an 11 question self-report questionnaire with each question scored on a scale of 1-4. Scores on this measure will allow us to consider whether individual differences in the reward value of sexual activity account for differences in performance and neural correlates of the PSD task.
Time frame: Sixth Task
Sexual Desire Inventory
This will be used to assess interest in sexual activity. It is a 14-question self-report questionnaire with each question scored on a scale of 0-8, where higher scores reflect more sexual desire. It typically takes less than 10 minutes to complete. Scores on this measure will allow us to consider whether individual differences in the reward value of sexual activity account for differences in performance and neural correlates of the PSD task.
Time frame: Fourth Task
Risk MRI Task
During scanning, participants will be shown two squares: a "safe" square and a "risk" square. If the participant chooses the "safe" square, they will earn a set amount of money ($0.25); if they choose the "risk" square, they have the possibility of winning up to $5.00 but also the possibility of losing up to $5.00. Across 40 trials, participants will be able to earn between $0 and $35. All events will be shown for 2 seconds with 2, 4, or 6 second jittered intervals between.
Time frame: Eighth Task
Protected Sex Discounting Pre-Scan Portion
Participants will view 60 cards with an image of a clothed person, spread on a table in front of them so they can all be viewed at the same time. Participants will be instructed to select all the pictures of individuals who they would be willing to have casual sex with based on physical appearance if the circumstances were right. From the pictures of individuals who the participant indicated that they would have sex with, participants will be asked to select 1) the individual most and 2) least likely to have a STD, and 2) the individual they most and 4) least want to have sex with.
Time frame: Seventh Task
HIV-Knowledge Questionnaire
A 45-question self-report questionnaire that takes approximately 7 minutes to complete. It assesses how much the participant knows about how HIV is transmitted and prevented.
Time frame: First Task
HIV Risk-Taking Behavior Scale
Assesses quantitatively both intravenous drug use and sexual HIV risk behaviors. This includes 11 questions about sharing and cleaning needles, number of sexual partners, condom use, and sex work. Each item is scored on a scale of 0-5 where higher scores indicate more HIV risk. It takes less than 10 minutes to administer. Scores on this measure will allow us to consider whether performance and neural correlates of the PSD task are related to actual HIV risk behaviors in our sample.
Time frame: Second Task
HIV and Sexual Behaviors Interview
Used to collect additional information on HIV risk. This will include such topics as condom attitudes and negotiation, HIV testing and history of exposure, sexual activities, partner risk behaviors, and perceived risk. Information from this survey will allow us to consider whether performance and neural correlates of the PSD task are related to actual HIV risk behaviors in our sample.
Time frame: Third Task
Balanced Inventory of Desirable Responding
This will be used to measure social desirability bias. It is a 40-question self-report questionnaire that measures self-deceptive positivity and impression management. Number of items with extremely high agreement indicates level of desirable responding. We will use this to identify participants who may have inaccurately responded to questions about sexual history and HIV risk due to a desire to represent themselves better, and thus, might potentially bias our results in some way.
Time frame: Fifth Task
Plan to share: No
Ran from Mar 2021 to primary completion in Apr 2025, 48 months.
Of 32 non-industry phase 1 interventional studies under Alcohol Drinking, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 49. This study's 48 months is above that.
Counting every sponsor, half of 34 studies reached it within 37 months; a quarter within 21 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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