Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value
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|ClinicalTrials.gov Identifier: NCT04067765|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : February 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder Alcohol Drinking||Behavioral: Alcohol vs Neutral Cue Behavioral: Responsibility vs No Responsibility||Not Applicable|
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 and decreases in the presence of significant next-day responsibilities. 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 first 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.
The second aim is to investigate the changes in neural activity associated with decreases in the value of alcohol in response to next day responsibilities. To do so, a second study will use a within-subjects design, comparing demand-related neural activity following a standard instructional set and an instructional set that imposes a significant work-related responsibility the next day.
Using a novel neuroeconomics approach, these studies combine 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 these studies have high potential to significantly enhance the clinical relevance of alcohol neuroscience.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Participants will undergo a validated cue exposure protocol involving exposure to neutral beverage cues followed by exposure to alcohol beverage cues; A separate set of participants will undergo a validated next-day-responsibility protocol involving hypothetical scenarios with no-responsibility followed by hypothetical scenarios involving significant next-day responsibilities (e.g., vocational or academic responsibilities)|
|Masking:||None (Open Label)|
|Official Title:||Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||July 2024|
Experimental: Alcohol vs Neutral Cue
Within-subjects experimental manipulation of alcohol vs. neutral cues
Behavioral: Alcohol vs Neutral Cue
Participants will undergo a validated in-scanner alcohol cue exposure protocol involving passive viewing of images of alcohol beverages (beer, wine, liquor) and neutral beverages (water, soft drinks, juice).
Experimental: Responsibility vs No Responsibility
Within-subjects experimental manipulation of responsibility vs. no-responsibility condition
Behavioral: Responsibility vs No Responsibility
Participants will be presented with two hypothetical scenarios, involving either a significant responsibility the next day (i.e., an important work or academic-related obligation) or no responsibility (i.e., drinking on a typical occasion with no explicit obligations the next day)
- Alcohol demand decision making [ Time Frame: 1 hour during MRI scan ]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)
- Alcohol craving [ Time Frame: 1 hour during MRI scan ]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 [ Time Frame: 1 hour during MRI scan ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067765
|Contact: Michael Amlung, PhD||9055221155 ext email@example.com|
|St. Joseph's Healthcare Hamilton||Recruiting|
|Hamilton, Ontario, Canada, L8N3K7|
|Contact: Michael Amlung, PhD 9055221155 ext 39014 firstname.lastname@example.org|
|Principal Investigator:||Michael Amlung, PhD||McMaster University|