- 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. 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N3K7
- St. Joseph's Healthcare Hamilton
-
-
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: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alcohol Cue
Alcohol cue exposure in scanner
|
Participants will undergo a validated in-scanner alcohol cue exposure protocol involving passive viewing of images of alcohol beverages (beer, wine, or liquor)
|
Active Comparator: Neutral Cue
Neutral cue exposure in scanner
|
Participants will undergo a validated in-scanner alcohol cue exposure protocol involving passive viewing of images of neutral beverages (water).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
1 hour during MRI scan
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
1 hour during MRI scan
|
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
|
1 hour during MRI scan
|
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 (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
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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