Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067765
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE August 16, 2019
First Posted Date  ICMJE August 26, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value
Official Title  ICMJE Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value
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 or the presence of a significant next-day-responsibility (i.e., a work related obligation). 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. A second participant sample will make these decisions either in the presence of a significant next-day-responsibility or in the absence of any explicit responsibilities.
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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
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)
Primary Purpose: Other
Condition  ICMJE
  • Alcohol Use Disorder
  • Alcohol Drinking
Intervention  ICMJE
  • 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).
  • 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)
Study Arms  ICMJE
  • Experimental: Alcohol vs Neutral Cue
    Within-subjects experimental manipulation of alcohol vs. neutral cues
    Intervention: Behavioral: Alcohol vs Neutral Cue
  • Experimental: Responsibility vs No Responsibility
    Within-subjects experimental manipulation of responsibility vs. no-responsibility condition
    Intervention: Behavioral: Responsibility vs No Responsibility
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2019)
154
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Michael Amlung, PhD 9055221155 ext 39014 amlungm@mcmaster.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04067765
Other Study ID Numbers  ICMJE R01AA027255-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Amlung, PhD McMaster University
PRS Account McMaster University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP