Alcohol Use DisorderNCT04067765
Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value
A study testing Cue Exposure in people with Alcohol Use Disorder and Alcohol Drinking, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Drinking
- What is being tested?
- Cue Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.);
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- 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%)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alcohol Use Disorder, Alcohol Drinking
- Being tested
- Cue Exposure
- Keywords
- Alcohol, Neuroeconomics, Demand, Cues
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cue ExposureBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cue Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 outcomes (1)
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.
Measured: Collected immediately after the first neutral cue exposure and immediately after the first alcohol cue exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Participants will undergo a validated cue exposure protocol involving exposure to neutral beverage cues followed by exposure to alcohol beverage cues
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Amlung, PhD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067765
- Sponsor's protocol ID
- R01AA027255-01A1
- Status last verified
- Sep 2025
- First submitted
- 16 Aug 2019
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value
- ClinicalTrials.gov ID
- NCT04067765
- Acronym / sponsor ID
- R01AA027255-01A1
- Conditions
- Alcohol Use Disorder, Alcohol Drinking
- Keywords
- Alcohol, Neuroeconomics, Demand, Cues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Posted 9 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will undergo a validated cue exposure protocol involving exposure to neutral beverage cues followed by exposure to alcohol beverage cues
| Arm | Type | Receives |
|---|---|---|
| Neutral Cue, then Alcohol Cue | Experimental | Behavioral: Cue ExposureParticipants 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. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cue ExposureParticipants 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). | Behavioural | Neutral Cue, then Alcohol Cue |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
Alcohol Craving
Time frame: Collected immediately after the first neutral cue exposure and immediately after the first alcohol cue exposure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Amlung, PhD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cue Exposure in people with Alcohol Use Disorder and Alcohol Drinking, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.