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

NCT04360018 | Completed Phase 1

• 2 other identifiers: 20005720-AA-0057
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

Binge; Brain; Drinking; Decision; Risky

Outcome Measures

Primary Outcomes (1)

• 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).

  First Task

Secondary Outcomes (8)

• Sexual Sensation Seeking Scale

  Sixth Task

• Sexual Desire Inventory

  Fourth Task

• Risk MRI Task

  Eighth Task

• Protected Sex Discounting Pre-Scan Portion

  Seventh Task

• HIV-Knowledge Questionnaire

  First Task

Study Arms (2)

arm one

ACTIVE COMPARATOR

participants receive alcohol beverage

Other: Alcohol beverage

arm two

PLACEBO COMPARATOR

Placebo

Other: Placebo beverage

Interventions

Alcohol beverage OTHER

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.

arm one

Placebo beverage OTHER

The final drink will have the same volume of liquid as the alcohol beverage.

arm two

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Alcoholism; Binge-Eating Disorder

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Feeding and Eating Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Reza Momenan, Ph.D.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: March 18, 2021
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04-02

Locations

US (1)