Brain Responses to Contextual Influences on Drinking Decisions

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Drinking
• Intervention / Treatment: Behavioral: Responsibility condition

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Amlung, PhD; Phone Number: 785.864.0334; Email: mamlung@ku.edu

Study Locations

• United States
  • Kansas
    • Lawrence, Kansas, United States, 66045
      • Recruiting
      • Cofrin Logan Center for Addiction Research and Treatment
      • Contact: Michael Amlung, PhD; Phone Number: 785-864-0334; Email: mamlung@ku.edu
      • Principal Investigator: Michael Amlung, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 53 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Responsibility vs No Responsibility; Within-subjects experimental manipulation of responsibility vs. no-responsibility condition

Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: University of Kansas
• Investigators: Principal Investigator: Michael Amlung, PhD, University of Kansas

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: STUDY00147117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 (https://neurovault.org/), 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.
• IPD Sharing Time Frame: Data will be posted at conclusion of study
• IPD Sharing Access Criteria: Data will be publicly available to researchers who create an account on neurovault.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No