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Brain Responses to Contextual Influences on Drinking Decisions

Brain Responses to Contextual Influences on Drinking Decisions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04895033
Enrollment
52
Registered
2021-05-20
Start date
2023-02-01
Completion date
2025-07-31
Last updated
2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking

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).

Interventions

BEHAVIORALResponsibility 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

Sponsors

University of Kansas
CollaboratorOTHER
University of Kansas Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Alcohol demandDuring 1 hour MRI scanParticipants 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 activationDuring 1 hour MRI scanBlood-oxygen-level-dependent (BOLD) activity measured by functional magnetic resonance imaging

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026