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

Primary Purpose

Alcohol Use Disorder

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Alcohol beverage

Placebo beverage

About this trial

This is an interventional basic science trial for Alcohol Use Disorder focused on measuring Binge, Brain, Drinking, Decision, Risky

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Consuming on average less than 1 standard drinks per week or greater than 7 drinks/week (if female) or 14 drinks/week (if male) (based on the most recent measurement within the past 90 days Alcohol Timeline Followback)
Having less than one binge drinking episode per month on average (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 Alcohol Timeline Followback).
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.

Sites / Locations

National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

arm one

arm two

Arm Description

participants receive alcohol beverage

Placebo

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Sexual Sensation Seeking Scale

This will be used to assess interest in risky sexual activity. It is an 11 question self-report questionnaire with each question scored on a scale of 1-4. Scores on this measure will allow us to consider whether individual differences in the reward value of sexual activity account for differences in performance and neural correlates of the PSD task.

Sexual Desire Inventory

This will be used to assess interest in sexual activity. It is a 14-question self-report questionnaire with each question scored on a scale of 0-8, where higher scores reflect more sexual desire. It typically takes less than 10 minutes to complete. Scores on this measure will allow us to consider whether individual differences in the reward value of sexual activity account for differences in performance and neural correlates of the PSD task.

Risk MRI Task

During scanning, participants will be shown two squares: a "safe" square and a "risk" square. If the participant chooses the "safe" square, they will earn a set amount of money ($0.25); if they choose the "risk" square, they have the possibility of winning up to $5.00 but also the possibility of losing up to $5.00. Across 40 trials, participants will be able to earn between $0 and $35. All events will be shown for 2 seconds with 2, 4, or 6 second jittered intervals between.

Protected Sex Discounting Pre-Scan Portion

Participants will view 60 cards with an image of a clothed person, spread on a table in front of them so they can all be viewed at the same time. Participants will be instructed to select all the pictures of individuals who they would be willing to have casual sex with based on physical appearance if the circumstances were right. From the pictures of individuals who the participant indicated that they would have sex with, participants will be asked to select 1) the individual most and 2) least likely to have a STD, and 2) the individual they most and 4) least want to have sex with.

HIV-Knowledge Questionnaire

A 45-question self-report questionnaire that takes approximately 7 minutes to complete. It assesses how much the participant knows about how HIV is transmitted and prevented.

HIV Risk-Taking Behavior Scale

Assesses quantitatively both intravenous drug use and sexual HIV risk behaviors. This includes 11 questions about sharing and cleaning needles, number of sexual partners, condom use, and sex work. Each item is scored on a scale of 0-5 where higher scores indicate more HIV risk. It takes less than 10 minutes to administer. Scores on this measure will allow us to consider whether performance and neural correlates of the PSD task are related to actual HIV risk behaviors in our sample.

HIV and Sexual Behaviors Interview

Used to collect additional information on HIV risk. This will include such topics as condom attitudes and negotiation, HIV testing and history of exposure, sexual activities, partner risk behaviors, and perceived risk. Information from this survey will allow us to consider whether performance and neural correlates of the PSD task are related to actual HIV risk behaviors in our sample.

Balanced Inventory of Desirable Responding

This will be used to measure social desirability bias. It is a 40-question self-report questionnaire that measures self-deceptive positivity and impression management. Number of items with extremely high agreement indicates level of desirable responding. We will use this to identify participants who may have inaccurately responded to questions about sexual history and HIV risk due to a desire to represent themselves better, and thus, might potentially bias our results in some way.

Full Information

NCT ID

NCT04360018

First Posted

April 22, 2020

Last Updated

August 24, 2023

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT04360018

Brief Title

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

2. Study Status

Record Verification Date

August 18, 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 18, 2021 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

Keywords

Binge, Brain, Drinking, Decision, Risky

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare Provider

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

arm one

Arm Type

Active Comparator

Arm Description

participants receive alcohol beverage

Arm Title

arm two

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Other

Intervention Name(s)

Alcohol beverage

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo beverage

Intervention Description

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

Primary Outcome Measure Information:

Title

Protected Sex Discounting MRI-Scan Portion

Description

Time Frame

First Task

Secondary Outcome Measure Information:

Title

Sexual Sensation Seeking Scale

Description

Time Frame

Sixth Task

Title

Sexual Desire Inventory

Description

Time Frame

Fourth Task

Title

Risk MRI Task

Description

Time Frame

Eighth Task

Title

Protected Sex Discounting Pre-Scan Portion

Description

Time Frame

Seventh Task

Title

HIV-Knowledge Questionnaire

Description

A 45-question self-report questionnaire that takes approximately 7 minutes to complete. It assesses how much the participant knows about how HIV is transmitted and prevented.

Time Frame

First Task

Title

HIV Risk-Taking Behavior Scale

Description

Time Frame

Second Task

Title

HIV and Sexual Behaviors Interview

Description

Time Frame

Third Task

Title

Balanced Inventory of Desirable Responding

Description

Time Frame

Fifth Task

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: 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: 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 Followback. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beth A Lee, R.N.

Phone

(301) 451-6964

beth.lee@nih.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Reza Momenan, Ph.D.

Phone

(301) 451-6972

rezam@nih.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reza Momenan, Ph.D.

Organizational Affiliation

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Phone

800-411-1222

Ext

TTY8664111010

prpl@cc.nih.gov

12. IPD Sharing Statement

Links:

URL

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2020-AA-0057.html

Description

NIH Clinical Center Detailed Web Page

Learn more about this trial

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

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