Inhibitory Control Smartphone App

Drinking Behavior Clinical Trial

Official title:

A Smartphone App to Capture Inhibitory Control as a Novel Moderate Drinking Tool for Young Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04243759
• Other study ID #: IRB202001530
• Secondary ID: R21AA026918IRB20
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: May 31, 2024

Study information

• Verified date: September 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 25 Years

Eligibility

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 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)

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

• Body weight less than 110 pounds or greater than 220 pounds

• Be colorblind

• Be a Foreign National

Related Conditions & MeSH terms

• Alcohol Drinking
• Drinking Behavior
• Drinking, Alcohol

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	UF Health at the University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in estimated Blood Alcohol Content (eBAC)	Study team will calculate peak estimated BAC (eBAC) based on number of alcoholic drinks, time elapsed, weight and sex.	Day 1
Primary	Change in number of alcoholic drinks consumed.	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.	Day 1 - Day 29