NCT04895033

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

2.5 years

First QC Date

May 12, 2021

Last Update Submit

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

EXPERIMENTAL

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

Behavioral: 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

Responsibility vs No Responsibility

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Cofrin Logan Center for Addiction Research and Treatment

Lawrence, Kansas, 66045, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Michael Amlung, PhD

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: The study uses a within-subjects design with all participants completing the no-responsibility and responsibility conditions.
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

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.

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

Locations