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Inhibitory Control Smartphone App

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243759
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Drinking, Alcohol Drinking Behavior Behavioral: Control App Version Behavioral: Standard App Version Behavioral: Experimental, Feedback App Version Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 groups of 3 in a naturalistic lab, followed by app use, then 1-hr when they can self-administer alcohol up to .12%. 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.
Masking: Double (Participant, Care Provider)
Masking Description: Staff working with participants will not know app assignment.
Primary Purpose: Prevention
Official Title: A Smartphone App to Capture Inhibitory Control as a Novel Moderate Drinking Tool for Young Adults
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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).

Behavioral: 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: 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.
Behavioral: 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.

Behavioral: 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: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in estimated Blood Alcohol Content (eBAC) [ Time Frame: Day 1 ]
    Study team will calculate peak estimated BAC (eBAC) based on number of alcoholic drinks, time elapsed, weight and sex.

  2. Change in number of alcoholic drinks consumed. [ Time Frame: Day 1 - Day 29 ]
    Entails comparisons of alcoholic drinks consumed per occasion between the 2 weeks participants will use vs. not use the app in the 4-week field period post-drinking session.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 six 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)
  • Self-report interest in using a smartphone app to help reduce drinking with a score of at least 3 on a 0-10 scale

Exclusion Criteria:

  • 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
  • A body mass index lower than 18.5 or greater than 35.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243759


Contacts
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Contact: Bonnie Rowland, BS 352-294-7538 bonnie.rowland@ufl.edu

Locations
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United States, Florida
UF Health at the University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Robert Leeman, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04243759    
Other Study ID Numbers: IRB202001530
R21AA026918 ( U.S. NIH Grant/Contract )
IRB201801604 - N ( Other Identifier: UF IRB )
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drinking Behavior
Alcohol Drinking