Clinical trial NCT04243759: Inhibitory Control Smartphone App
Official title: A Smartphone App to Capture Inhibitory Control as a Novel Moderate Drinking Tool for Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drinking, Alcohol
Drinking Behavior
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-01-28
Enrollment: 53
Sex: ALL
Minimum age (years): 21
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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 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

Primary outcomes:
measure: Number of Alcoholic Drinks Intended to Consume if They Were Free (i.e., Intensity)
timeFrame: Day 1
measure: Change in Number of Alcoholic Drinks Consumed Per Occasion
timeFrame: Two weeks with full app access versus two weeks without during the 4-week field use period
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Liana Hone, MS, MPH, PHD
role: PRINCIPAL_INVESTIGATOR
References: