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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 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.
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. The 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 an experimental manipulation that models 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, this study 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neutral Cue, then Alcohol Cue | Experimental | Participants first completed an in-scanner neutral cue exposure prior to the first two in-scanner alcohol purchase tasks runs. Participants then received an in-scanner alcohol cue exposure prior to the final two in-scanner alcohol purchase task runs. Cue exposures consisted of images of neutral (water) or alcohol (beer, wine, liquor) beverages and an imaginal script describing a drinking scenario. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cue Exposure | Behavioral | Participants will undergo a validated in-scanner alcohol cue and neutral cue exposure protocol involving passive viewing of images of alcohol beverages (beer, wine, or liquor) and neutral beverages (water). |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Demand Intensity | Intensity is defined as the self-consumption in standard drinks at free price. Participants could select between 0-10 standard sized alcohol drinks on the in-scanner alcohol purchase task paradigm. The mean intensity was calculated separately for the two neutral cue runs and the two alcohol cue runs. | Collected during each of 4 runs of the FMRI Alcohol Purchase Task. Duration of each run was approximately 6 minutes and included 26 trials. |
| Alcohol Demand Breakpoint | Breakpoint is defined as the first price on the alcohol purchase task that suppressed consumption to zero drinks. The mean breakpoint was calculated separately for the two neutral cue runs and the two alcohol cue runs. | Collected during each of 4 runs of the FMRI Alcohol Purchase Task. Duration of each run was approximately 6 minutes and included 26 trials. |
| Alcohol Demand Omax | Omax is defined as the maximum total expenditure on alcohol for the in-scanner alcohol purchase task. The mean Omax was calculated separately for the two neutral cue runs and the two alcohol cue runs. | Collected during each of 4 runs of the FMRI Alcohol Purchase Task. Duration of each run was approximately 6 minutes and included 26 trials. |
| Alcohol Demand Elasticity | Elasticity is defined as the change in consumption (in drinks) as a function of increases in price per drink (in dollars). This index was modeled using an exponentiated demand curve model as reported in [Koffarnus, M. N., Franck, C. T., Stein, J. S., & Bickel, W. K. (2015). A modified exponential behavioral economic demand model to better describe consumption data. Experimental and clinical psychopharmacology, 23(6), 504-512. https://doi.org/10.1037/pha0000045\]. This nonlinear model generates a best fitting value for an alpha parameter, reflecting the rate of change in elasticity over increasing price. Higher alpha values reflect greater elasticity (greater sensitivity in consumption with increases in price). There is no theoretical range as this is a free parameter in the model. Mean alpha values were calculated separately for the two neutral cue runs and the two alcohol cue runs. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Craving | Subjective alcohol craving was assessed using three 100-point scales, including how much they want alcohol, crave alcohol, and their urge for alcohol. A score of 0 indicates the lowest level of craving; a score of 100 indicates the highest amount of craving. The three items were averaged into a composite craving score. | Collected immediately after the first neutral cue exposure and immediately after the first alcohol cue exposure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Amlung, PhD | University of Kansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N3K7 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cue Exposure | Within subjects assignment to receive complete both an alcohol cue exposure and neutral cue exposure in a sequential order (neutral followed by alcohol cues. Each run was preceded by a slideshow of pictures of neutral or alcohol beverages. Following standard practice in laboratory cue exposure paradigms, the neutral cues were presented first (prior to runs 1-2) followed by the alcohol cues (prior to runs 3-4) to minimize potential of carryover effects. Neutral cues depicted various water beverages and alcohol cues depicted the participant's preferred alcohol type (beer, wine, or liquor). Each exposure included 30 cues presented for 3s each. Prior to the first neutral and alcohol cue run, an imaginal cue script was read aloud to the participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neutral Cue Exposure (5 Minutes Total) |
| |||||||||||||
| Alcohol Cue Exposure (5 Minutes Total) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcohol Cue Exposure | Within subjects assignment to receive complete both an alcohol cue exposure and neutral cue exposure in a sequential order. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Diagnostic Assessment Research Tool (DART) DSM-5 Alcohol Use Disorder |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol Demand Intensity | Intensity is defined as the self-consumption in standard drinks at free price. Participants could select between 0-10 standard sized alcohol drinks on the in-scanner alcohol purchase task paradigm. The mean intensity was calculated separately for the two neutral cue runs and the two alcohol cue runs. | Posted | Mean | Standard Error | Drinks | Collected during each of 4 runs of the FMRI Alcohol Purchase Task. Duration of each run was approximately 6 minutes and included 26 trials. |
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Baseline visit to MRI scan visit. Median time frame = 23 days (minimum time frame 2 days; maximum time frame 88 days)
Standard definition of adverse event and serious adverse event were used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neutral Cue Exposure | Neutral cue exposure during fMRI scan | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Amlung | University of Kansas | 785-864-0334 | mamlung@ku.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2023 | Jun 30, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2024 | Jul 1, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 10, 2020 | Jun 13, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Participants will undergo a validated cue exposure protocol involving exposure to neutral beverage cues followed by exposure to alcohol beverage cues
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| Collected during each of 4 runs of the FMRI Alcohol Purchase Task. Duration of each run was approximately 6 minutes and included 26 trials. |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Alcohol Use Disorders Identification Test (AUDIT) | The Alcohol Use Disorders Identification Test is a 10-item screening questionnaire assessing quantity/frequency of alcohol consumption and alcohol-related problems experienced over the last 12 months. All items are summed to generate a total AUDIT score, with scores ranging from 0-40. Higher scores representing greater alcohol use disorder severity. | Mean | Standard Deviation | units on a scale |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Education | Years of Education | Mean | Standard Deviation | Years |
|
| Daily Drinking Questionnaire (DDQ) | Drinks per week calculated from Daily Drinking Questionnaire | Mean | Standard Deviation | Drinks/week |
|
| Diagnostic Assessment Research Tool (DART) for DSM-5 Alcohol Use Disorder | Semi-structured clinical interview assessing DSM-5 alcohol use disorder diagnoses. Participants received a diagnosis of alcohol use disorder if they endorsed 2 or more criteria on the DART interview. Variable reflects the count of participants meeting DSM-5 criteria for alcohol use disorder. | Count of Participants | Participants | No |
|
| 30 Day Timeline Follow-Back Interview | Drinks per week calculated from 30-day alcohol timeline follow-back interview | Mean | Standard Deviation | Drinks/week |
|
| Participants |
|
|
| Primary | Alcohol Demand Breakpoint | Breakpoint is defined as the first price on the alcohol purchase task that suppressed consumption to zero drinks. The mean breakpoint was calculated separately for the two neutral cue runs and the two alcohol cue runs. | Posted | Mean | Standard Error | Dollars | Collected during each of 4 runs of the FMRI Alcohol Purchase Task. Duration of each run was approximately 6 minutes and included 26 trials. |
|
|
|
| Primary | Alcohol Demand Omax | Omax is defined as the maximum total expenditure on alcohol for the in-scanner alcohol purchase task. The mean Omax was calculated separately for the two neutral cue runs and the two alcohol cue runs. | Posted | Mean | Standard Error | Dollars | Collected during each of 4 runs of the FMRI Alcohol Purchase Task. Duration of each run was approximately 6 minutes and included 26 trials. |
|
|
|
| Primary | Alcohol Demand Elasticity | Elasticity is defined as the change in consumption (in drinks) as a function of increases in price per drink (in dollars). This index was modeled using an exponentiated demand curve model as reported in [Koffarnus, M. N., Franck, C. T., Stein, J. S., & Bickel, W. K. (2015). A modified exponential behavioral economic demand model to better describe consumption data. Experimental and clinical psychopharmacology, 23(6), 504-512. https://doi.org/10.1037/pha0000045\]. This nonlinear model generates a best fitting value for an alpha parameter, reflecting the rate of change in elasticity over increasing price. Higher alpha values reflect greater elasticity (greater sensitivity in consumption with increases in price). There is no theoretical range as this is a free parameter in the model. Mean alpha values were calculated separately for the two neutral cue runs and the two alcohol cue runs. | Posted | Mean | Standard Error | drinks consumed/price (dollars) | Collected during each of 4 runs of the FMRI Alcohol Purchase Task. Duration of each run was approximately 6 minutes and included 26 trials. |
|
|
|
| Secondary | Alcohol Craving | Subjective alcohol craving was assessed using three 100-point scales, including how much they want alcohol, crave alcohol, and their urge for alcohol. A score of 0 indicates the lowest level of craving; a score of 100 indicates the highest amount of craving. The three items were averaged into a composite craving score. | Posted | Mean | Standard Error | Points | Collected immediately after the first neutral cue exposure and immediately after the first alcohol cue exposure. |
|
|
|
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | Alcohol Cue Exposure | Alcohol cue exposure during fMRI scan | 0 | 72 | 0 | 72 | 0 | 72 |
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| D004327 | Drinking Behavior |
| D001519 | Behavior |