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| ID | Type | Description | Link |
|---|---|---|---|
| R21AA026918 | U.S. NIH Grant/Contract | View source | |
| IRB201801604 - N | Other Identifier | UF IRB |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The proposed study will address a critical knowledge gap: there are no evidence-based smartphone apps for reducing young adult drinking. The purpose of the study is to test alcohol-related smartphone applications designed to provide assistance during actual drinking situations to help young adults reduce their drinking. It is the researchers hypothesis that participants will self-administer less alcohol when using the experimental app with feedback.
An app giving in-the-moment feedback could increase perceived impairment, and reduce drinking and consequences.
The cued go/no-go (CGNG) task is an ideal choice for in-the-moment impairment feedback. Its instructions are simple; practice effects are minimal; and is sensitive to alcohol. The CGNG tests ability to respond fast to "go" targets (activation) while withholding response to "no-go" targets (inhibition). Activation/inhibition tension is externally valid. Dual process models posit risk behaviors stem from overactive appetitive drives that are compelling and hard to inhibit. Poor CGNG performance post-alcohol has been related to poor simulated driving, enhancing external validity. Moderate dosing to .05-.06% blood alcohol content (BAC) reliably increases inhibition errors, but slowing reaction time (RT) to "go" cues requires higher doses. RT to go cues often recovers later in a drinking episode (acute tolerance) but ability to inhibit does not. Thus at this BAC, ability to respond remains but inhibition is impaired, which relates to risk behaviors like DUI as young adults underrate impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control App Group | Experimental | 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. |
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| Standard App Group | Experimental | 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. |
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| Experimental, Feedback App Group | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control App Version | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Alcoholic Drinks Intended to Consume if They Were Free (i.e., Intensity) | 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. | Day 1 |
| Change in Number of Alcoholic Drinks Consumed Per Occasion | 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. | Two weeks with full app access versus two weeks without during the 4-week field use period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liana Hone, MS, MPH, PHD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health at the University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Alcoholic Drinks Intended to Consume if They Were Free (i.e., Intensity) | 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. | Only participants who completed a laboratory alcohol administration session | Posted | Mean | Standard Deviation | drinks | Day 1 |
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A period up to about six weeks including screening period, laboratory session and field use period.
standard adverse event and serious adverse event descriptions were used
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Leeman | Northeastern University | 6173736501 | r.leeman@northeastern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2023 | Jun 16, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 12, 2023 | Jul 22, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D004327 | Drinking Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Heavy drinking young adults will be randomized to 1 of the 3 apps. After initial use of their randomized app, they will then be dosed to .06% blood alcohol content (BAC) in a naturalistic lab, followed by app use. For 4 weeks post-session, all participants will use the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks.
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Staff working with participants will not know app assignment.
| Standard App Version | Behavioral | 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. |
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| Experimental, Feedback App Version | Behavioral | 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. |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| intensity on State Version of the Alcohol Purchase Task | 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. | Mean | Standard Deviation | drinks |
|
| drinks per drinking day | Mean | Standard Deviation | standard alcoholic drinks |
|
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. |
| OG001 | 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. |
| OG002 | 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. |
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| Primary | Change in Number of Alcoholic Drinks Consumed Per Occasion | 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. | 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 | Posted | Mean | Standard Deviation | standard alcoholic drinks | Two weeks with full app access versus two weeks without during the 4-week field use period |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | Experimental, Feedback App During Field Use Period | Participants enrolled to participate in the four-week field period with or without the laboratory alcohol drinking session. | 0 | 53 | 0 | 53 | 0 | 53 |
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