Trial Outcomes & Findings for Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value (NCT NCT04067765)
NCT ID: NCT04067765
Last Updated: 2025-09-09
Results Overview
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.
COMPLETED
NA
72 participants
Collected during each of 4 runs of the FMRI Alcohol Purchase Task. Duration of each run was approximately 6 minutes and included 26 trials.
2025-09-09
Participant Flow
Participant milestones
| Measure |
Cue Exposure
Within subjects assignment to receive complete both an alcohol cue exposure and neutral cue exposure in a sequential order (neutral followed by alcohol cues. Each run was preceded by a slideshow of pictures of neutral or alcohol beverages. Following standard practice in laboratory cue exposure paradigms, the neutral cues were presented first (prior to runs 1-2) followed by the alcohol cues (prior to runs 3-4) to minimize potential of carryover effects. Neutral cues depicted various water beverages and alcohol cues depicted the participant's preferred alcohol type (beer, wine, or liquor). Each exposure included 30 cues presented for 3s each. Prior to the first neutral and alcohol cue run, an imaginal cue script was read aloud to the participant.
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|---|---|
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Neutral Cue Exposure (5 Minutes Total)
STARTED
|
72
|
|
Neutral Cue Exposure (5 Minutes Total)
COMPLETED
|
72
|
|
Neutral Cue Exposure (5 Minutes Total)
NOT COMPLETED
|
0
|
|
Alcohol Cue Exposure (5 Minutes Total)
STARTED
|
72
|
|
Alcohol Cue Exposure (5 Minutes Total)
COMPLETED
|
72
|
|
Alcohol Cue Exposure (5 Minutes Total)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value
Baseline characteristics by cohort
| Measure |
Alcohol Cue Exposure
n=72 Participants
Within subjects assignment to receive complete both an alcohol cue exposure and neutral cue exposure in a sequential order.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
72 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Alcohol Use Disorders Identification Test (AUDIT)
|
12.0 units on a scale
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Education
|
16.3 Years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Daily Drinking Questionnaire (DDQ)
|
22.3 Drinks/week
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Diagnostic Assessment Research Tool (DART) for DSM-5 Alcohol Use Disorder
|
49 Participants
n=5 Participants
|
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30 Day Timeline Follow-Back Interview
|
20.3 Drinks/week
STANDARD_DEVIATION 12.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Alcohol Cue Exposure
n=72 Participants
Within subjects assignment to receive complete both an alcohol cue exposure and neutral cue exposure in a sequential order.
|
|---|---|
|
Alcohol Demand Intensity
Neutral Cue Exposure
|
7.42 Drinks
Standard Error 0.30
|
|
Alcohol Demand Intensity
Alcohol Cue Exposure
|
7.85 Drinks
Standard Error 0.27
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Alcohol Cue Exposure
n=68 Participants
Within subjects assignment to receive complete both an alcohol cue exposure and neutral cue exposure in a sequential order.
|
|---|---|
|
Alcohol Demand Breakpoint
Neutral Cue Exposure
|
28.77 Dollars
Standard Error 1.67
|
|
Alcohol Demand Breakpoint
Alcohol Cue Exposure
|
32.48 Dollars
Standard Error 1.45
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Alcohol Cue Exposure
n=72 Participants
Within subjects assignment to receive complete both an alcohol cue exposure and neutral cue exposure in a sequential order.
|
|---|---|
|
Alcohol Demand Omax
Neutral Cue Exposure
|
49.54 Dollars
Standard Error 6.32
|
|
Alcohol Demand Omax
Alcohol Cue Exposure
|
60.63 Dollars
Standard Error 8.39
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Alcohol Cue Exposure
n=72 Participants
Within subjects assignment to receive complete both an alcohol cue exposure and neutral cue exposure in a sequential order.
|
|---|---|
|
Alcohol Demand Elasticity
Neutral Cue Exposure
|
0.006 drinks consumed/price (dollars)
Standard Error 0.001
|
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Alcohol Demand Elasticity
Alcohol Cue Exposure
|
0.003 drinks consumed/price (dollars)
Standard Error 0.001
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SECONDARY outcome
Timeframe: Collected immediately after the first neutral cue exposure and immediately after the first alcohol cue exposure.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.
Outcome measures
| Measure |
Alcohol Cue Exposure
n=72 Participants
Within subjects assignment to receive complete both an alcohol cue exposure and neutral cue exposure in a sequential order.
|
|---|---|
|
Alcohol Craving
neutral cue exposure
|
19.72 Points
Standard Error 2.49
|
|
Alcohol Craving
alcohol cue exposure
|
27.99 Points
Standard Error 2.84
|
Adverse Events
Neutral Cue Exposure
Alcohol Cue Exposure
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place