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Brain Responses to Contextual Influences on Drinking Decisions

NCT ID: NCT04895033

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-07-31

Brief Summary

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This study is using functional magnetic resonance imaging (fMRI) to examine brain activity associated with making decisions about drinking alcohol in everyday situations, some of which may involve important activities happening the next day. The secondary aims are to determine whether severity of alcohol-related problems is related to brain activity and alcohol choices and to examine how different areas of the brain interact in connected networks.

Detailed Description

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The overall objective of this study is to examine brain activity associated with making decisions about drinking alcohol in everyday situations, some of which may involve important activities happening the next day. The secondary aims are to determine whether severity of alcohol-related problems is related to brain activity and alcohol choices and to examine how different areas of the brain interact in connected networks. The study involves two testing sessions -- a baseline interview conducted virtually or in-person, and a MRI scanning session at University of Kansas Medical Center. Participants (N=80, 50% female, age 21-55) are community adults who report drinking alcohol in excess of NIAAA-recommended weekly drinking limits (i.e., heavy drinkers who consume 14/7+ drinks per week for men/women). Participants will complete hypothetical alcohol purchase tasks during the MRI scan with two conditions being examined. A control condition involves a typical drinking situation with no explicit responsibilities. An experimental condition involves a hypothetical situation with important personally-relevant responsibilities the next day (e.g., a presentation at work, an exam, or caregiving responsibilities).

Conditions

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Alcohol Drinking

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study uses a within-subjects design with all participants completing the no-responsibility and responsibility conditions.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Responsibility vs No Responsibility

Within-subjects experimental manipulation of responsibility vs. no-responsibility condition

Group Type EXPERIMENTAL

Responsibility condition

Intervention Type BEHAVIORAL

During the fMRI scan, participants will complete alcohol purchase task paradigm for hypothetical alcohol rewards under two conditions. In the next-day responsibility condition, we will present a vignette describing a drinking scenario in which participants have a significant activity the next day (e.g., a work, family, or academic obligation the next morning) and participants are asked to imagine they are deciding how much they want to drink in this situation. The control condition will use a vignette describing a typical drinking scenario with no explicit responsibilities the next day

Interventions

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Responsibility condition

During the fMRI scan, participants will complete alcohol purchase task paradigm for hypothetical alcohol rewards under two conditions. In the next-day responsibility condition, we will present a vignette describing a drinking scenario in which participants have a significant activity the next day (e.g., a work, family, or academic obligation the next morning) and participants are asked to imagine they are deciding how much they want to drink in this situation. The control condition will use a vignette describing a typical drinking scenario with no explicit responsibilities the next day

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. 21-55 years of age;
2. current heavy alcohol drinking in the past three months, as indicated by reporting consumption of 14 or more drinks per week for men or 7 or more drinks per week for women and at least one heavy drinking episode weekly (5+/4+ drinks in a single occasion for males/females);
3. belong to a category with significant responsibilities, such as being currently employed, a current student, or a caregiver with significant responsibilities;
4. speak English;
5. normal or corrected to normal vision and hearing;
6. able to give informed consent.

Exclusion Criteria

1. currently engaged in treatment or seeking treatment for alcohol-related problems;
2. major psychiatric illness (psychotic disorder, bipolar disorder, post-traumatic stress disorder);
3. Diagnostic and Statistical Manual Version-5 substance use disorder (except nicotine);
4. attending any in-person session with a positive breath alcohol concentration (BrAC \> 0.00%);
5. any contraindications for MRI scanning (e.g., metal in body surgically or accidentally including pacemaker, cochlear implants, aneurysm clips, shrapnel, etc.);
6. history of seizures or anti-seizure medication;
7. history of concussion or other significant brain injury;
8. serious medical illness unsuitable for the MRI scanner based on best clinical judgment
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kansas

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Amlung, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

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Cofrin Logan Center for Addiction Research and Treatment

Lawrence, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00147117

Identifier Type: -

Identifier Source: org_study_id