search
Back to results

Brain Responses to Contextual Influences on Drinking Decisions

Primary Purpose

Alcohol Drinking

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Responsibility condition
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Drinking

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cofrin Logan Center for Addiction Research and TreatmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Responsibility vs No Responsibility

Arm Description

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

Outcomes

Primary Outcome Measures

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)
Brain activation
Blood-oxygen-level-dependent (BOLD) activity measured by functional magnetic resonance imaging

Secondary Outcome Measures

Full Information

First Posted
May 12, 2021
Last Updated
May 24, 2023
Sponsor
University of Kansas Medical Center
Collaborators
University of Kansas
search

1. Study Identification

Unique Protocol Identification Number
NCT04895033
Brief Title
Brain Responses to Contextual Influences on Drinking Decisions
Official Title
Brain Responses to Contextual Influences on Drinking Decisions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
University of Kansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study uses a within-subjects design with all participants completing the no-responsibility and responsibility conditions.
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Responsibility vs No Responsibility
Arm Type
Experimental
Arm Description
Within-subjects experimental manipulation of responsibility vs. no-responsibility condition
Intervention Type
Behavioral
Intervention Name(s)
Responsibility condition
Intervention Description
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
Primary Outcome Measure Information:
Title
Alcohol demand
Description
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)
Time Frame
During 1 hour MRI scan
Title
Brain activation
Description
Blood-oxygen-level-dependent (BOLD) activity measured by functional magnetic resonance imaging
Time Frame
During 1 hour MRI scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 21-55 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Amlung, PhD
Phone
785.864.0334
Email
mamlung@ku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Amlung, PhD
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cofrin Logan Center for Addiction Research and Treatment
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Amlung, PhD
Phone
785-864-0334
Email
mamlung@ku.edu
First Name & Middle Initial & Last Name & Degree
Michael Amlung, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Brain Responses to Contextual Influences on Drinking Decisions

We'll reach out to this number within 24 hrs