Clinical trial NCT04360018: Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors
Official title: The Effect of Acute Alcohol Intoxication on Neural Processes During Decisions to Engage in HIV Risk Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Use Disorder
Keywords: Binge
Brain
Drinking
Decision
Risky
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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)

Eligibility criteria: * INCLUSION CRITERIA:
* 21 to 65 years old.

EXCLUSION CRITERIA for Alcohol Administration/MR scanning:

* 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.

Primary outcomes:
measure: Protected Sex Discounting MRI-Scan Portion
timeFrame: First Task
Secondary outcomes:
measure: Sexual Sensation Seeking Scale
timeFrame: Sixth Task
measure: Sexual Desire Inventory
timeFrame: Fourth Task
measure: Risk MRI Task
timeFrame: Eighth Task
measure: Protected Sex Discounting Pre-Scan Portion
timeFrame: Seventh Task
measure: HIV-Knowledge Questionnaire
timeFrame: First Task
measure: HIV Risk-Taking Behavior Scale
timeFrame: Second Task
measure: HIV and Sexual Behaviors Interview
timeFrame: Third Task
measure: Balanced Inventory of Desirable Responding
timeFrame: Fifth Task
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Reza Momenan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: