Inhibitory Control Smartphone App

NCT04243759 | Completed Results

• 3 other identifiers: IRB202001530R21AA026918IRB201801604 - N
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drinking, Alcohol; Drinking Behavior

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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.

Behavioral: Control App Version; Behavioral: Experimental, Feedback App Version

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.

Behavioral: Standard App Version; Behavioral: Experimental, Feedback App Version

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.

Behavioral: Experimental, Feedback App Version

Interventions

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).

Control App Group

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.

Standard App Group

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.

Control App Group; Experimental, Feedback App Group; Standard App Group

Eligibility Criteria

• Age: 21 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be able to read English and complete study evaluations
• Report drinking to an estimated blood alcohol concentration (eBAC) of 0.12% (i.e., the maximum allowable BAC in the alcohol drinking sessions in this study) or higher at least once in the prior 30 days
• Report at least four days with heavy episodic drinking (i.e., 4 or more drinks for women and 5 or more drinks for men) out of the prior 30 days
• Report having consumed at least one alcoholic drink during a minimum of 12 days out of the prior 30 in order to maximize the likelihood that subjects will choose to drink during the self-administration portion of the laboratory sessions.
• Meet, at minimum, DSM-5 criteria for a mild alcohol use disorder (i.e., meet at least 2 diagnostic criteria)
• Perform within 2 standard deviations of normative levels both with regard to reaction time and number of errors on the cued go/no-go task at in-person screening
• Have an iphone/iOS-compatible phone that they are willing to use for study-related tasks (field use-only participants from outside of the Gainesville area, only; local participants will have an opportunity to borrow a study phone)

You may not qualify if:

• Be seeking treatment for alcohol or other addictive behaviors or have been in inpatient or intensive outpatient treatment within the past 12 months
• Have used a smartphone application to facilitate moderate drinking more than 1 time within the past 12 months
• Provide two positive breath alcohol concentration (BrAC) readings (i.e., \> 0.00%) at an in-person screening appointment or on the day of the alcohol drinking session. After participants blow their first positive BrAC, they will be allowed to reschedule and participate at another time, however if they blow a second positive BrAC, they will be excluded from this study and offered referrals for alcohol treatment.
• Have positive urine screen results at the in-person screening or on the day of an alcohol drinking session for opiates, cocaine, phencyclidine, amphetamines, methamphetamine, barbiturates, methadone or benzodiazepines.
• Meet criteria for current nicotine dependence or dependence on any other drug, excluding alcohol.
• Report current use of psychotropic drugs including anxiolytics and antidepressants.
• Have received a prescription for any psychotropic drug in the 30 days prior to study enrollment
• Be psychotic or otherwise severely psychiatrically disabled
• Report a history of a medical condition that would contraindicate the consumption of alcohol (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders).
• Have a history of clinically significant withdrawal from alcohol, defined as any one of the following: a) a lifetime history of seizures, delirium, or hallucinations during alcohol withdrawal; b) a Clinical Institute Withdrawal Assessment scale (CIWA-Ar, Sullivan et al., 1989) score \> 8; c) a report of drinking to avoid withdrawal symptoms in the past 12 months; or d) a lifetime history of medical treatment for withdrawal.
• A woman who is pregnant, nursing, or refuses to use a reliable method of birth control.
• Report disliking vodka or vodka mixed drinks. Vodka is the alcoholic beverage participants to be used in the proposed study
• Body weight less than 110 pounds or greater than 220 pounds
• Be colorblind
• Be a Foreign National

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Drinking Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Robert Leeman
• Organization: Northeastern University

r.leeman@northeastern.edu

6173736501

Study Officials

• Liana Hone, MS, MPH, PHD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Staff working with participants will not know app assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 28, 2020
• Study Start: November 9, 2020
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2024
• Last Updated: May 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)