An interventional study of Control App Version and Standard App Version in Drinking, Alcohol and Drinking Behavior, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 21 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by University of Florida · Not applicable, Interventional, and Prevention
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.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 53 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Control App Version · Behavioral: Experimental, Feedback App Version
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.
Behavioral: Standard App Version · Behavioral: Experimental, Feedback App Version
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.
Behavioral: Experimental, Feedback 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).
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.
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)
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.
Time frame: 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.
Time frame: Two weeks with full app access versus two weeks without during the 4-week field use period
| Milestone | Control App Condition | Standard App Condition | Experimental, Feedback App Condition | Field Period Only Participants |
|---|---|---|---|---|
| Started | 14 | 12 | 14 | 13 |
| Completed | 13 | 12 | 14 | 13 |
| Not completed | 1 | 0 | 0 | 0 |
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.
| drinks | Control App Group | Standard App Group | Experimental, Feedback App Group |
|---|---|---|---|
| Number of Alcoholic Drinks Intended to Consume if They Were Free (i.e., Intensity) | 6.92 ± 3.28 | 7.33 ± 3.63 | 6.71 ± 4.48 |
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.
| standard alcoholic drinks | All Participants Who Completed the Field Use Period |
|---|---|
| 2 weeks with full intervention app access | 5.37 ± 2.60 |
| 2 weeks without full intervention app access | 5.01 ± 2.31 |
Collected over A period up to about six weeks including screening period, laboratory session and field use period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control App Condition | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Standard App Condition | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Experimental, Feedback App Condition | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Experimental, Feedback App During Field Use Period | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Age, Categorical(Participants) | Control App Group | Standard App Group | Experimental, Feedback App Group | Field Period Only Participants | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 12 | 14 | 13 | 53 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Control App Group | Standard App Group | Experimental, Feedback App Group | Field Period Only Participants | Total |
|---|---|---|---|---|---|
| Mean | 22.07 ± 1.44 | 22.08 ± 1.08 | 22.07 ± 1.49 | 21.69 ± 0.95 | 21.98 ± 1.25 |
| Sex: Female, Male(Participants) | Control App Group | Standard App Group | Experimental, Feedback App Group | Field Period Only Participants | Total |
|---|---|---|---|---|---|
| Female | 9 | 6 | 3 | 10 | 28 |
| Male | 5 | 6 | 11 | 3 | 25 |
| Ethnicity (NIH/OMB)(Participants) | Control App Group | Standard App Group | Experimental, Feedback App Group | Field Period Only Participants | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 5 | 4 | 4 | 1 | 14 |
| Not Hispanic or Latino | 9 | 8 | 10 | 12 | 39 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control App Group | Standard App Group | Experimental, Feedback App Group | Field Period Only Participants | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 0 | 1 |
| Asian | 1 | 1 | 0 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 13 | 9 | 13 | 12 | 47 |
| More than one race | 0 | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 1 |
| Region of Enrollment(participants) | Control App Group | Standard App Group | Experimental, Feedback App Group | Field Period Only Participants | Total |
|---|---|---|---|---|---|
| United States | 14 | 12 | 14 | 13 | 53 |
| intensity on State Version of the Alcohol Purchase Task(drinks) | Control App Group | Standard App Group | Experimental, Feedback App Group | Field Period Only Participants | Total |
|---|---|---|---|---|---|
| Mean | 6.92 ± 3.28 | 7.33 ± 3.63 | 6.71 ± 4.48 | 6.97 ± 3.76 | 6.97 ± 3.76 |
| drinks per drinking day(standard alcoholic drinks) | Control App Group | Standard App Group | Experimental, Feedback App Group | Field Period Only Participants | Total |
|---|---|---|---|---|---|
| Mean | 5.28 ± 1.28 | 6.27 ± 3.04 | 5.04 ± 0.99 | 5.47 ± 1.38 | 5.49 ± 1.81 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2020 to primary completion in May 2023, 30 months.
Results were first posted in May 2025, 1 year 11 months after primary completion.
Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 30 months is above that.
Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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