Trial Outcomes & Findings for Inhibitory Control Smartphone App (NCT NCT04243759)
NCT ID: NCT04243759
Last Updated: 2025-05-30
Results Overview
Number of alcoholic drinks participants report an intention to consume at no cost on the state version of the Alcohol Purchase Task following alcohol administration in the lab. The State Version of the Alcohol Purchase Task is a behavioral economic measure capturing number of drinks participants report an intention to consume now at different price points, provided they were able to drink. Hypothetical costs range from free to $15 each. Higher numbers of self-reported, intended drinks indicates greater motivation to consume alcohol. At each price point, number of drinks can range from 0 to 25. The Alcohol Purchase Task yields several variables, but in this outcome, we considered only intensity, i.e., number of drinks one reports they would have if they were free.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
Day 1
Results posted on
2025-05-30
Participant Flow
Participant milestones
| Measure |
Control App Condition
Young Adult Drinkers will be randomized to 1 of the 3 app conditions (Control App Version; Standard App Version; Experimental, Feedback App Version). The apps will be tested both during a laboratory alcohol drinking session and a 4-week period outside the lab in which they can use this technology in actual drinking situations. For the 4-week period outside the lab, all participants will use the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks.
Control App Version: The control version is a smartphone-compatible CGNG. The cued go/no-go (CGNG) tests ability to respond fast to "go" targets (activation) while withholding response to "no-go" targets (inhibition).
|
Standard App Condition
Young Adult Drinkers will be randomized to 1 of the 3 app conditions (Control App Version; Standard App Version; Experimental, Feedback App Version). The apps will be tested both during a laboratory alcohol drinking session and a 4-week period outside the lab in which they can use this technology in actual drinking situations. For the 4-week period outside the lab, all participants will use the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks.
Standard App Version: The standard version is the same as the control version with the exception that information about performance (correct or incorrect) is displayed along with RT in ms for a correct response during each inter-trial interval.
|
Experimental, Feedback App Condition
Young Adult Drinkers will be randomized to 1 of the 3 app conditions (Control App Version; Standard App Version; Experimental, Feedback App Version). The apps will be tested both during a laboratory alcohol drinking session and a 4-week period outside the lab in which they can use this technology in actual drinking situations. For the 4-week period outside the lab, all participants will use the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks.
Experimental, Feedback App Version: The experimental, feedback version includes the standard plus feedback on RT and inhibition errors compared to pre-drinking. The app will state that there are simple alternatives with invitation to press a box to view advice, based on research that risk information may increase risky behavior if convenient options are not given73. Feedback will be worded non-judgmentally per motivational interviewing tenets.
|
Field Period Only Participants
A subset of participants were enrolled to participate in the four-week field period only with no laboratory alcohol drinking session.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
14
|
13
|
|
Overall Study
COMPLETED
|
13
|
12
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inhibitory Control Smartphone App
Baseline characteristics by cohort
| Measure |
Control App Group
n=14 Participants
Young Adult Drinkers will be randomized to 1 of the 3 app conditions (Control App Version; Standard App Version; Experimental, Feedback App Version). The apps will be tested both during a laboratory alcohol drinking session and a 4-week period outside the lab in which they can use this technology in actual drinking situations. For the 4-week period outside the lab, all participants will use the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks.
Control App Version: The control version is a smartphone-compatible CGNG. The cued go/no-go (CGNG) tests ability to respond fast to "go" targets (activation) while withholding response to "no-go" targets (inhibition).
Experimental, Feedback App Version: The experimental, feedback version includes the standard plus feedback on RT and inhibition errors compared to pre-drinking. The app will state that there are simple alternatives with invitation to press a box to view advice, based on research that risk information may increase risky behavior if convenient options are not given73. Feedback will be worded non-judgmentally per motivational interviewing tenets.
|
Standard App Group
n=12 Participants
Young Adult Drinkers will be randomized to 1 of the 3 app conditions (Control App Version; Standard App Version; Experimental, Feedback App Version). The apps will be tested both during a laboratory alcohol drinking session and a 4-week period outside the lab in which they can use this technology in actual drinking situations. For the 4-week period outside the lab, all participants will use the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks.
Standard App Version: The standard version is the same as the control version with the exception that information about performance (correct or incorrect) is displayed along with RT in ms for a correct response during each inter-trial interval.
Experimental, Feedback App Version: The experimental, feedback version includes the standard plus feedback on RT and inhibition errors compared to pre-drinking. The app will state that there are simple alternatives with invitation to press a box to view advice, based on research that risk information may increase risky behavior if convenient options are not given73. Feedback will be worded non-judgmentally per motivational interviewing tenets.
|
Experimental, Feedback App Group
n=14 Participants
Young Adult Drinkers will be randomized to 1 of the 3 app conditions (Control App Version; Standard App Version; Experimental, Feedback App Version). The apps will be tested both during a laboratory alcohol drinking session and a 4-week period outside the lab in which they can use this technology in actual drinking situations. For the 4-week period outside the lab, all participants will use the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks.
Experimental, Feedback App Version: The experimental, feedback version includes the standard plus feedback on RT and inhibition errors compared to pre-drinking. The app will state that there are simple alternatives with invitation to press a box to view advice, based on research that risk information may increase risky behavior if convenient options are not given73. Feedback will be worded non-judgmentally per motivational interviewing tenets.
|
Field Period Only Participants
n=13 Participants
A subset of participants were enrolled to participate in the four-week field period only with no laboratory alcohol drinking session.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
22.07 years
STANDARD_DEVIATION 1.44 • n=5 Participants
|
22.08 years
STANDARD_DEVIATION 1.08 • n=7 Participants
|
22.07 years
STANDARD_DEVIATION 1.49 • n=5 Participants
|
21.69 years
STANDARD_DEVIATION 0.95 • n=4 Participants
|
21.98 years
STANDARD_DEVIATION 1.25 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
14 participants
n=5 Participants
|
13 participants
n=4 Participants
|
53 participants
n=21 Participants
|
|
intensity on State Version of the Alcohol Purchase Task
|
6.92 drinks
STANDARD_DEVIATION 3.28 • n=5 Participants
|
7.33 drinks
STANDARD_DEVIATION 3.63 • n=7 Participants
|
6.71 drinks
STANDARD_DEVIATION 4.48 • n=5 Participants
|
6.97 drinks
STANDARD_DEVIATION 3.76 • n=4 Participants
|
6.97 drinks
STANDARD_DEVIATION 3.76 • n=21 Participants
|
|
drinks per drinking day
|
5.28 standard alcoholic drinks
STANDARD_DEVIATION 1.28 • n=5 Participants
|
6.27 standard alcoholic drinks
STANDARD_DEVIATION 3.04 • n=7 Participants
|
5.04 standard alcoholic drinks
STANDARD_DEVIATION 0.99 • n=5 Participants
|
5.47 standard alcoholic drinks
STANDARD_DEVIATION 1.38 • n=4 Participants
|
5.49 standard alcoholic drinks
STANDARD_DEVIATION 1.81 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Only participants who completed a laboratory alcohol administration session
Number of alcoholic drinks participants report an intention to consume at no cost on the state version of the Alcohol Purchase Task following alcohol administration in the lab. The State Version of the Alcohol Purchase Task is a behavioral economic measure capturing number of drinks participants report an intention to consume now at different price points, provided they were able to drink. Hypothetical costs range from free to $15 each. Higher numbers of self-reported, intended drinks indicates greater motivation to consume alcohol. At each price point, number of drinks can range from 0 to 25. The Alcohol Purchase Task yields several variables, but in this outcome, we considered only intensity, i.e., number of drinks one reports they would have if they were free.
Outcome measures
| Measure |
Control App Group
n=13 Participants
Young Adult Drinkers will be randomized to 1 of the 3 app conditions (Control App Version; Standard App Version; Experimental, Feedback App Version). The apps will be tested both during a laboratory alcohol drinking session and a 4-week period outside the lab in which they can use this technology in actual drinking situations. For the 4-week period outside the lab, all participants will use the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks.
Control App Version: The control version is a smartphone-compatible CGNG. The cued go/no-go (CGNG) tests ability to respond fast to "go" targets (activation) while withholding response to "no-go" targets (inhibition).
Experimental, Feedback App Version: The experimental, feedback version includes the standard plus feedback on RT and inhibition errors compared to pre-drinking. The app will state that there are simple alternatives with invitation to press a box to view advice, based on research that risk information may increase risky behavior if convenient options are not given73. Feedback will be worded non-judgmentally per motivational interviewing tenets.
|
Standard App Group
n=12 Participants
Young Adult Drinkers will be randomized to 1 of the 3 app conditions (Control App Version; Standard App Version; Experimental, Feedback App Version). The apps will be tested both during a laboratory alcohol drinking session and a 4-week period outside the lab in which they can use this technology in actual drinking situations. For the 4-week period outside the lab, all participants will use the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks.
Standard App Version: The standard version is the same as the control version with the exception that information about performance (correct or incorrect) is displayed along with RT in ms for a correct response during each inter-trial interval.
Experimental, Feedback App Version: The experimental, feedback version includes the standard plus feedback on RT and inhibition errors compared to pre-drinking. The app will state that there are simple alternatives with invitation to press a box to view advice, based on research that risk information may increase risky behavior if convenient options are not given73. Feedback will be worded non-judgmentally per motivational interviewing tenets.
|
Experimental, Feedback App Group
n=14 Participants
Young Adult Drinkers will be randomized to 1 of the 3 app conditions (Control App Version; Standard App Version; Experimental, Feedback App Version). The apps will be tested both during a laboratory alcohol drinking session and a 4-week period outside the lab in which they can use this technology in actual drinking situations. For the 4-week period outside the lab, all participants will use the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks.
Experimental, Feedback App Version: The experimental, feedback version includes the standard plus feedback on RT and inhibition errors compared to pre-drinking. The app will state that there are simple alternatives with invitation to press a box to view advice, based on research that risk information may increase risky behavior if convenient options are not given73. Feedback will be worded non-judgmentally per motivational interviewing tenets.
|
|---|---|---|---|
|
Number of Alcoholic Drinks Intended to Consume if They Were Free (i.e., Intensity)
|
6.92 drinks
Standard Deviation 3.28
|
7.33 drinks
Standard Deviation 3.63
|
6.71 drinks
Standard Deviation 4.48
|
PRIMARY outcome
Timeframe: Two weeks with full app access versus two weeks without during the 4-week field use periodPopulation: The 4-arm approach was appropriate for Primary Aim 1 when participants were randomized to 1 of 3 experimental conditions in the lab, as opposed to those who did not complete a lab session. However, for these field use analyses, since all participants had the same experience, within subjects comparisons among the entire sample that completed the field period were most appropriate. Thus, these analyses include those who completed a lab session and those who completed the field use period only
Entails comparisons of alcoholic drinks consumed per occasion between the 2 weeks participants had full app access vs. the 2 weeks they did not have full app access during the 4-week field use period after the alcohol drinking session.
Outcome measures
| Measure |
Control App Group
n=53 Participants
Young Adult Drinkers will be randomized to 1 of the 3 app conditions (Control App Version; Standard App Version; Experimental, Feedback App Version). The apps will be tested both during a laboratory alcohol drinking session and a 4-week period outside the lab in which they can use this technology in actual drinking situations. For the 4-week period outside the lab, all participants will use the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks.
Control App Version: The control version is a smartphone-compatible CGNG. The cued go/no-go (CGNG) tests ability to respond fast to "go" targets (activation) while withholding response to "no-go" targets (inhibition).
Experimental, Feedback App Version: The experimental, feedback version includes the standard plus feedback on RT and inhibition errors compared to pre-drinking. The app will state that there are simple alternatives with invitation to press a box to view advice, based on research that risk information may increase risky behavior if convenient options are not given73. Feedback will be worded non-judgmentally per motivational interviewing tenets.
|
Standard App Group
Young Adult Drinkers will be randomized to 1 of the 3 app conditions (Control App Version; Standard App Version; Experimental, Feedback App Version). The apps will be tested both during a laboratory alcohol drinking session and a 4-week period outside the lab in which they can use this technology in actual drinking situations. For the 4-week period outside the lab, all participants will use the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks.
Standard App Version: The standard version is the same as the control version with the exception that information about performance (correct or incorrect) is displayed along with RT in ms for a correct response during each inter-trial interval.
Experimental, Feedback App Version: The experimental, feedback version includes the standard plus feedback on RT and inhibition errors compared to pre-drinking. The app will state that there are simple alternatives with invitation to press a box to view advice, based on research that risk information may increase risky behavior if convenient options are not given73. Feedback will be worded non-judgmentally per motivational interviewing tenets.
|
Experimental, Feedback App Group
Young Adult Drinkers will be randomized to 1 of the 3 app conditions (Control App Version; Standard App Version; Experimental, Feedback App Version). The apps will be tested both during a laboratory alcohol drinking session and a 4-week period outside the lab in which they can use this technology in actual drinking situations. For the 4-week period outside the lab, all participants will use the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks.
Experimental, Feedback App Version: The experimental, feedback version includes the standard plus feedback on RT and inhibition errors compared to pre-drinking. The app will state that there are simple alternatives with invitation to press a box to view advice, based on research that risk information may increase risky behavior if convenient options are not given73. Feedback will be worded non-judgmentally per motivational interviewing tenets.
|
|---|---|---|---|
|
Change in Number of Alcoholic Drinks Consumed Per Occasion
2 weeks with full intervention app access
|
5.37 standard alcoholic drinks
Standard Deviation 2.60
|
—
|
—
|
|
Change in Number of Alcoholic Drinks Consumed Per Occasion
2 weeks without full intervention app access
|
5.01 standard alcoholic drinks
Standard Deviation 2.31
|
—
|
—
|
Adverse Events
Control App Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard App Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental, Feedback App Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental, Feedback App During Field Use Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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