Alcohol Use and Mental Health - Pilot Test of Video-assisted Drinking Topography

Phase 4

Terminated

• Conditions: Alcohol Use Disorder
• Interventions: Drug: Beer; Device: Videotaped drinking session

• Registration Number: NCT03314454
• Lead Sponsor: University of Florida

Brief Summary

The overall goal is to pilot test and establish a procedure for video-assisted alcohol topography and explore its utility as an indicator of alcohol use disorder. There are 4 phases to this study: 1) pre-screening by phone; 2) in-person screening appointment; 3) the first alcohol drinking session with videotaping; and 4) follow-up appointment for retest.

Detailed Description

Alcohol use especially high-risk drinking remains a serious public health concern. Recent calls for "precision intervention" require more in-depth understanding of drinking behavioral patterns for more individualized treatment. Currently, alcohol research has relied on self-reported questionnaire or biomarkers to measure alcohol use. However, self-reports are often subjected to social desirability bias or recall errors; whereas biomarkers are prone to measurement errors, confounders for false positives, and individual variations in alcohol metabolism. There is need for an objective, reliable, and nonintrusive way to measure alcohol use with high ecological validity.

Topography can provide objective measures of consumption behavior patterns in fine grained detail. While it has been widely used in tobacco research, alcohol topography has not been well-studied. Smoking topography has been shown to provide indicative information for nicotine dependence. The investigators hypothesize that alcohol topography can also be used as an objective measure indicative of alcohol use disorder. In this project, the investigators propose to conduct a video-assisted drinking topographical study. The main objectives of this study include: (1) characterize drinking behavioral patterns by converting videotaped drinking episodes into various drinking related parameters (e.g., sipping frequency, sipping interval, sipping duration, rest duration, sipping amount, and etc.); (2) compare drinking behavioral patterns across groups defined by drinking status (social vs. heavy drinkers) and mental health status (depressed vs. non-depressed); and (3) use advanced nonlinear modeling to quantify the behavioral pattern and to derive potential indicators for alcohol use disorder.

This will be the first study to ever use videotaped topography to analyze alcohol drinking behavioral pattern using a quantum model and link it to alcohol use disorder. The study will be conducted in the simulated bar laboratory located in Yon Hall at the University of Florida (UF). Conducting alcohol topography in such a setting greatly enhances ecological validity, further increasing the capacity of this method to capture real life drinking patterns and to potentially detect alcohol use disorder.

Study Timeline

• Study First Submitted: 2017-10-04
• Study Start: 2017-10-12
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-19
• Primary Completion: 2022-12-15
• Study Completion: 2023-06-01
• Results First Submitted: 2024-03-14
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Results First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Be able to read/write English and complete study assessments
• Drink alcohol
• Healthy adults reporting alcohol consumption in the past 30 days
• Not currently seeking treatment for substance use
• Willingness to provide urine drug screening

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Exclusion Criteria

• Test positive on a urine test for use of certain illegal drugs
• Undergraduate student enrolled at the University of Florida
• Graduate students from the College of Health and Human Performance at the University of Florida
• Pregnant, or currently breast feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elevated Mental Status	Beer	Elevated score on Patient Health Questionnaire
Elevated Mental Status	Videotaped drinking session	Elevated score on Patient Health Questionnaire
Non-elevated depressed mood	Beer	Lower score on Patient Health Questionnaire
Non-elevated depressed mood	Videotaped drinking session	Lower score on Patient Health Questionnaire
Social Drinking status	Beer	The social drinker group will be those who consume alcohol regularly but with infrequent heavy drinking days.
Social Drinking status	Videotaped drinking session	The social drinker group will be those who consume alcohol regularly but with infrequent heavy drinking days.
Heavy drinker status	Beer	The heavy drinker group will be those who consume alcohol regularly with frequent heavy drinking days.
Heavy drinker status	Videotaped drinking session	The heavy drinker group will be those who consume alcohol regularly with frequent heavy drinking days.

Primary Outcome Measures

Name	Time	Method
Alcohol Topography: Sip Frequency	60 days (from phone screening to follow-up retest)	To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean number of sips per alcoholic drink
Alcohol Topography: Sip Interval	60 days (from phone screening to follow-up retest)	To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean interval between sips
Alcohol Topography: Sip Duration	60 days (from phone screening to follow-up retest)	To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean sip duration
Alcohol Topography: Sip Amount.	60 days (from phone screening to follow-up retest)	To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in multiple ways including the current measure: mean amount of beer consumed per sip

Trial Locations

Locations (1)

EDGE Laboratory; 🇺🇸 Gainesville, Florida, United States