Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04067765 |
| Other study ID # |
R01AA027255-01A1 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
McMaster University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
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.
