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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-AA-0057

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 21
Max Age: 65

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking;
Pregnant Women and Fetuses;
Children

Special Instructions

Currently Not Provided

Keywords

Binge;
Brain;
Drinking;
Decision;
Risky

Recruitment Keyword(s)

None

Condition(s)

Alcohol Use Disorder

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Alcohol beverage
Other: Placebo beverage

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

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.

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Eligibility

INCLUSION CRITERIA:

1. 21 to 65 years old.

2. 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)

3. 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:

1. Currently seeking treatment for alcohol use disorder

2. Significant history of head trauma or cranial surgery

3. History of neurological disease based on self-report and neuromotor physical exam, conducted by a health care provider, that would interfere with neuroimaging research.

4. Have fulfilled DSM-5 criteria for a substance use disorder, other than alcohol use disorder

5. History of any psychosis

6. 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;

7. HIV positive

8. Currently taking PrEP

9. Female participants only (or other individuals able to get pregnant): Currently pregnant or breastfeeding

10. Any flag on the NIAAA MRI Safety Screening Questionnaire, unless cleared by medically responsible staff (MD/NP)

11. Reported to have a facial, body, and limb flushing response to the consumption of alcohol, as determined by the Alcohol Flushing Questionnaire

12. Unable to understand and communicate in English at a level sufficient to provide documented informed consent in English


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Reza Momenan, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)



Isabella E. Rosario
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room 1-5413
10 Center Drive
Bethesda, Maryland 20892
(301) 435-0686
isabella.rosario@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04360018

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