Brain Responses to Contextual Influences on Drinking Decisions
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedNovember 14, 2025
November 1, 2025
2.5 years
May 12, 2021
November 13, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Alcohol demand
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)
During 1 hour MRI scan
Brain activation
Blood-oxygen-level-dependent (BOLD) activity measured by functional magnetic resonance imaging
During 1 hour MRI scan
Study Arms (1)
Responsibility vs No Responsibility
EXPERIMENTALWithin-subjects experimental manipulation of responsibility vs. no-responsibility condition
Interventions
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
Eligibility Criteria
You may qualify if:
- years of age;
- 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);
- belong to a category with significant responsibilities, such as being currently employed, a current student, or a caregiver with significant responsibilities;
- speak English;
- normal or corrected to normal vision and hearing;
- able to give informed consent.
You may not qualify if:
- currently engaged in treatment or seeking treatment for alcohol-related problems;
- major psychiatric illness (psychotic disorder, bipolar disorder, post-traumatic stress disorder);
- Diagnostic and Statistical Manual Version-5 substance use disorder (except nicotine);
- attending any in-person session with a positive breath alcohol concentration (BrAC \> 0.00%);
- any contraindications for MRI scanning (e.g., metal in body surgically or accidentally including pacemaker, cochlear implants, aneurysm clips, shrapnel, etc.);
- history of seizures or anti-seizure medication;
- history of concussion or other significant brain injury;
- serious medical illness unsuitable for the MRI scanner based on best clinical judgment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kansas Medical Centerlead
- University of Kansascollaborator
Study Sites (1)
Cofrin Logan Center for Addiction Research and Treatment
Lawrence, Kansas, 66045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Amlung, PhD
University of Kansas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2021
First Posted
May 20, 2021
Study Start
February 1, 2023
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
November 14, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be posted at conclusion of study
- Access Criteria
- Data will be publicly available to researchers who create an account on neurovault.org
After the study is complete, the researchers are encouraged by NIH funding guidelines to deposit de-identified fMRI data and associated baseline data into a public access archive such as NeuroVault, a secure repository where researchers can publicly store and share unthresholded statistical maps, parcellations, and atlases produced by fMRI studies. The investigators will take all necessary steps to ensure that only de-identified data is made publicly available.