NCT04067765

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

September 9, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

August 16, 2019

Results QC Date

June 16, 2025

Last Update Submit

September 4, 2025

Conditions

Keywords

AlcoholNeuroeconomicsDemandCues

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    Collected immediately after the first neutral cue exposure and immediately after the first alcohol cue exposure.

Study Arms (1)

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.

Behavioral: Cue Exposure

Interventions

Cue ExposureBEHAVIORAL

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).

Neutral Cue, then Alcohol Cue

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N3K7, Canada

Location

MeSH Terms

Conditions

AlcoholismAlcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Results Point of Contact

Title
Dr. Michael Amlung
Organization
University of Kansas

Study Officials

  • Michael Amlung, PhD

    University of Kansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Participants will undergo a validated cue exposure protocol involving exposure to neutral beverage cues followed by exposure to alcohol beverage cues
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 26, 2019

Study Start

January 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 9, 2025

Results First Posted

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations