Brain Responses to Contextual Influences on Drinking Decisions

Not Applicable

Active, not recruiting

• Conditions: Alcohol Drinking
• Interventions: Behavioral: Responsibility condition

• Registration Number: NCT04895033
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-20
• Study Start: 2023-02-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Responsibility vs No Responsibility	Responsibility condition	Within-subjects experimental manipulation of responsibility vs. no-responsibility condition

Primary Outcome Measures

Name	Time	Method
Alcohol demand	During 1 hour MRI scan	Participants will report how many standard drinks they would consume at varying prices using a hypothetical Alcohol Purchase Task (APT) procedure. The APT is a validated self-report measure of alcohol consumption (in standard drink units) at escalating prices (18 price intervals, ranging from $0 to $80/drink). Responses on APT are analyzed to generate observed and derived indices of alcohol demand, including: intensity (consumption at free price); breakpoint (maximum price for spent for a single drink); Omax (maximum expenditure on alcohol); and Elasticity (proportionate slope of the alcohol demand curve)
Brain activation	During 1 hour MRI scan	Blood-oxygen-level-dependent (BOLD) activity measured by functional magnetic resonance imaging

Trial Locations

Locations (1)

Cofrin Logan Center for Addiction Research and Treatment; 🇺🇸 Lawrence, Kansas, United States