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Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value

Primary Purpose

Alcohol Use Disorder, Alcohol Drinking

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Alcohol cue
Neutral cue
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Use Disorder focused on measuring Alcohol, Neuroeconomics, Demand, Cues

Eligibility Criteria

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

Inclusion Criteria:

  • 21-55 years old;
  • Right-handed;
  • Fluent English speaker;
  • Heavy drinker (i.e., on average > 14/7 drinks per week for males/females in past three months;
  • Average of 1 heavy drinking episode weekly (heavy drinking episode = 5+/4+ for males/females) over past three months

Exclusion Criteria:

  • Currently receiving treatment, or seeking treatment, for alcohol related problems;
  • Current Diagnostic and Statistical Manual (DSM-5) substance use disorder other than alcohol or tobacco;
  • Weekly or more frequent use of recreational drugs;
  • History of schizophrenia-spectrum disorders, psychotic disorders, bipolar disorder, or PTSD;
  • History of neurocognitive disorder or impairment;
  • MRI contraindications (e.g., metal in body, history of seizure, etc.);
  • History of serious brain injury;
  • Currently taking psychotropic medications or medications that could affect cerebral blood flow;
  • Pregnancy (females);
  • Attending any study session with a positive breath alcohol concentration (BrAC > 0.00g%)

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alcohol Cue

Neutral Cue

Arm Description

Alcohol cue exposure in scanner

Neutral cue exposure in scanner

Outcomes

Primary Outcome Measures

Alcohol demand decision making
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)

Secondary Outcome Measures

Alcohol craving
Self-reported subjective ratings of craving and urge for alcohol using a 100-point visual analogue scale, from 0 (no urge/craving for alcohol) to 100 (maximum urge/craving for alcohol)
Subjective affect
Self-reported subjective ratings of positive and negative affect, using 10-point visual analogue scales assessing the following affect dimensions: happy, sad, bored, stressed, and relaxed

Full Information

First Posted
August 16, 2019
Last Updated
August 14, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT04067765
Brief Title
Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value
Official Title
Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

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 uses techniques from an area of research known as neuroeconomics, which integrates concepts and methods from psychology, neuroscience, and economics to better understand how people make decisions and how these decisions are supported by the brain. One neuroeconomic concept that is especially relevant in the area of addictions is substance demand, or how consumption of a commodity (e.g., alcohol, tobacco, or drugs) is influenced by price and other factors. Previous studies have shown that alcohol demand is related to severity of alcohol misuse, drinking quantity/frequency, and treatment outcomes. In addition, we know that alcohol demand can also fluctuate in response to environmental cues such as alcohol-related stimuli or external contingencies such as important responsibilities the following day. These increase and decreases in consumption and value are clinically significant because they help us understand how people with alcohol use disorders are able to successfully or unsuccessfully modulate their drinking behaviors. This study is examining how the brain responds in these situations and whether these responses differ as a function of severity of alcohol misuse. This study will use functional magnetic resonance imaging (fMRI) to understand brain activity patterns associated with changes in the value of alcohol in the presence of alcohol-related beverage cues relative to neutral-related beverage cue. Participants will be non-treatment-seeking adult heavy drinkers who are recruited from the community to participate in an fMRI scan. During the scan, participants will make decisions about how many alcohol beverages they would consume (hypothetically) at various prices while their brain activity during those decisions is measured. The first experimental manipulation involves an in-scanner alcohol cue exposure task in which the drinking decisions will be made after viewing high-quality images of alcoholic (beer/wine/liquor) beverages or neutral (water/juice/soft drinks) beverages.
Detailed Description
Neuroeconomics integrates concepts and methods from psychology, economics, and cognitive neuroscience to understand the neurobiological foundations of decision making, and has been increasingly applied to understanding alcohol use disorder (AUD). A novel application of neuroeconomics is the study of alcohol demand, or the value of alcohol as measured by cost-benefit preferences. Alcohol demand paradigms have considerable ecological validity by measuring the impact of internal and external influences on alcohol decision-making, such as price, environmental cues, affective states, or external contingencies. Behaviorally, alcohol demand is elevated among individuals with higher levels of alcohol misuse and predicts treatment response. Alcohol demand also exhibits state-like properties, including increases following exposure to alcohol-related cues. The overall goal of the proposed studies is to characterize the neural activity that subserves these established behavioral findings using a novel functional MRI paradigm. The primary aim is to examine the patterns of neural activation underlying increases in the value of alcohol in response to alcohol cues. To do so, the first study will use a within-subjects design to identify differences in neural activity associated with demand decisions following a validated in-scanner cue exposure protocol consisting of exposure to neutral beverage cues and exposure to alcohol beverage cues in a sample of adult heavy drinkers. Using a novel neuroeconomics approach, this study combines a highly ecologically-valid alcohol demand paradigm with two experimental manipulations that model clinically-relevant influences on drinking decisions. Studying these contextual influences may help clarify the neural signatures that underlie drinking moderation vs. unconstrained drinking, and how these processes are impacted by AUD. If successful, these studies will provide a foundation for examining neural predictors of successful recovery or response to treatment vs. relapse. More broadly, findings from this study have high potential to significantly enhance the clinical relevance of alcohol neuroscience.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Alcohol Drinking
Keywords
Alcohol, Neuroeconomics, Demand, Cues

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will undergo a validated cue exposure protocol involving exposure to neutral beverage cues followed by exposure to alcohol beverage cues
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcohol Cue
Arm Type
Experimental
Arm Description
Alcohol cue exposure in scanner
Arm Title
Neutral Cue
Arm Type
Active Comparator
Arm Description
Neutral cue exposure in scanner
Intervention Type
Behavioral
Intervention Name(s)
Alcohol cue
Intervention Description
Participants will undergo a validated in-scanner alcohol cue exposure protocol involving passive viewing of images of alcohol beverages (beer, wine, or liquor)
Intervention Type
Behavioral
Intervention Name(s)
Neutral cue
Intervention Description
Participants will undergo a validated in-scanner alcohol cue exposure protocol involving passive viewing of images of neutral beverages (water).
Primary Outcome Measure Information:
Title
Alcohol demand decision making
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
1 hour during MRI scan
Secondary Outcome Measure Information:
Title
Alcohol craving
Description
Self-reported subjective ratings of craving and urge for alcohol using a 100-point visual analogue scale, from 0 (no urge/craving for alcohol) to 100 (maximum urge/craving for alcohol)
Time Frame
1 hour during MRI scan
Title
Subjective affect
Description
Self-reported subjective ratings of positive and negative affect, using 10-point visual analogue scales assessing the following affect dimensions: happy, sad, bored, stressed, and relaxed
Time Frame
1 hour during 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 old; Right-handed; Fluent English speaker; Heavy drinker (i.e., on average > 14/7 drinks per week for males/females in past three months; Average of 1 heavy drinking episode weekly (heavy drinking episode = 5+/4+ for males/females) over past three months Exclusion Criteria: Currently receiving treatment, or seeking treatment, for alcohol related problems; Current Diagnostic and Statistical Manual (DSM-5) substance use disorder other than alcohol or tobacco; Weekly or more frequent use of recreational drugs; History of schizophrenia-spectrum disorders, psychotic disorders, bipolar disorder, or PTSD; History of neurocognitive disorder or impairment; MRI contraindications (e.g., metal in body, history of seizure, etc.); History of serious brain injury; Currently taking psychotropic medications or medications that could affect cerebral blood flow; Pregnancy (females); Attending any study session with a positive breath alcohol concentration (BrAC > 0.00g%)
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
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3K7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value

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