Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    35
  • sponsor
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Updated on 28 February 2021
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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.

...

Description

Objective

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.

Study Population:

Healthy community participants who binge drink occasionally but do not have alcohol use disorder.

Design

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 a protected sex discounting task. At a second visit, participants will receive the opposite type of beverage

(alcohol or placebo). Participants will be randomly assigned to order of beverages.

Outcome

The primary outcome of this study is changes in neural activity during protect sex discounting during the alcohol compared to placebo visits. Behavioral changes (i.e., willingness to engage in unprotected sexual encounters) will also investigated as a primary outcome.

Details
Condition Alcohol abuse, Alcohol Use Disorder, Alcohol Use Disorders, Alcohol Dependence
Treatment Placebo Beverage, Alcohol beverage
Clinical Study IdentifierNCT04360018
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Last Modified on28 February 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: Alcohol Use Disorder or Alcohol Use Disorders or Alcohol abuse or Alcohol Dependence?
Do you have any of these conditions: Alcohol Dependence or Alcohol Use Disorders or Alcohol abuse or Alcohol Use Disorder?
Do you have any of these conditions: Alcohol Use Disorders or Alcohol Use Disorder or Alcohol abuse or Alcohol Dependence?
Do you have any of these conditions: Alcohol abuse or Alcohol Use Disorder or Alcohol Use Disorders or Alcohol Dependence?
Do you have any of these conditions: Alcohol Use Disorder or Alcohol Use Disorders or Alcohol Dependence or Alcohol abuse?
Do you have any of these conditions: Alcohol abuse or Alcohol Use Disorders or Alcohol Dependence or Alcohol Use Disorder?
Do you have any of these conditions: Alcohol abuse or Alcohol Use Disorder or Alcohol Use Disorders or Alcohol Dependence?
Do you have any of these conditions: Alcohol Use Disorder or Alcohol abuse or Alcohol Dependence or Alcohol Use Disorders?
Do you have any of these conditions: Alcohol Dependence or Alcohol abuse or Alcohol Use Disorders or Alcohol Use Disorder?
Do you have any of these conditions: Alcohol abuse or Alcohol Use Disorder or Alcohol Dependence or Alcohol Use Disorders?
Do you have any of these conditions: Alcohol abuse or Alcohol Dependence or Alcohol Use Disorders or Alcohol Use Disorder?
Do you have any of these conditions: Alcohol Use Disorders or Alcohol Use Disorder or Alcohol abuse or Alcohol Dependence?
Do you have any of these conditions: Alcohol abuse or Alcohol Dependence or Alcohol Use Disorders or Alcohol Use Disorder?
Do you have any of these conditions: Alcohol Dependence or Alcohol abuse or Alcohol Use Disorders or Alcohol Use Disorder?
Do you have any of these conditions: Alcohol Dependence or Alcohol Use Disorders or Alcohol Use Disorder or Alcohol abuse?
Is your age between 21 yrs and 65 yrs?
Do you have any of these conditions: Alcohol abuse or Alcohol Use Disorder or Alcohol Use Disorders or Alcohol Dependence?
Do you have any of these conditions: Alcohol abuse or Alcohol Use Disorder or Alcohol Use Disorders or Alcohol Dependence?
Do you have any of these conditions: Alcohol abuse or Alcohol Dependence or Alcohol Use Disorder or Alcohol Use Disorders?
Do you have any of these conditions: Alcohol abuse or Alcohol Dependence or Alcohol Use Disorders or Alcohol Use Disorder?
Do you have any of these conditions: Alcohol Use Disorder or Alcohol abuse or Alcohol Dependence or Alcohol Use Disorders?
Do you have any of these conditions: Alcohol Use Disorder or Alcohol abuse or Alcohol Use Disorders or Alcohol Dependence?
Do you have any of these conditions: Alcohol abuse or Alcohol Use Disorder or Alcohol Use Disorders or Alcohol Dependence?
Do you have any of these conditions: Alcohol Use Disorder or Alcohol abuse or Alcohol Dependence or Alcohol Use Disorders?
Do you have any of these conditions: Alcohol abuse or Alcohol Dependence or Alcohol Use Disorders or Alcohol Use Disorder?
Do you have any of these conditions: Alcohol abuse or Alcohol Use Disorders or Alcohol Use Disorder or Alcohol Dependence?
Do you have any of these conditions: Alcohol Use Disorder or Alcohol Dependence or Alcohol abuse or Alcohol Use Disorders?
Do you have any of these conditions: Alcohol abuse or Alcohol Dependence or Alcohol Use Disorder?
Gender: Male or Female
21 to 65 years old
Consuming on average between 1 and 7 standard drinks/week if female; between 1 and 14 standard drinks/week if male (as determined by the most recent measurement within the past 90 days Alcohol Timeline Follow back)
Having on average one or more binge drinking episodes per month (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 Alcohol Timeline Follow back)

Exclusion Criteria

Significant history of head trauma or cranial surgery
History of neurological disease based on self-report and neuromotor physical exam, conducted by a health care provider, that would interfere with neuroimaging research
Have fulfilled DSM-5 criteria for a substance or alcohol use disorder
History of any psychosis
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 NIAAA 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
Non English Speakers
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