- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04067765
Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value
Study Overview
Status
Conditions
Intervention / Treatment
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. 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N3K7
- St. Joseph's Healthcare Hamilton
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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%)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Neutral Cue, then Alcohol Cue
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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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol Demand Intensity
Time Frame: 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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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.
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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.
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Alcohol Demand Breakpoint
Time Frame: 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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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.
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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.
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Alcohol Demand Omax
Time Frame: 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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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.
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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.
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Alcohol Demand Elasticity
Time Frame: 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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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol Craving
Time Frame: Collected immediately after the first neutral cue exposure and immediately after the first alcohol cue exposure.
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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.
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Collected immediately after the first neutral cue exposure and immediately after the first alcohol cue exposure.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Amlung, PhD, University of Kansas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AA027255-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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