Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT04360018
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2020-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors
Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Organization:
Study Overview
Official Title:
The Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors
Status:
COMPLETED
Status Verified Date:
2025-04-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
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)
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)
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 20-AA-0057 | None | None | View |