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

NCT ID: NCT03314454

Last Updated: 2024-12-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-12

Study Completion Date

2023-06-01

Brief Summary

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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

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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.

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participants are aware of the interventions, but are not aware of the assigned arm.

Study Groups

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Elevated Mental Status

Elevated score on Patient Health Questionnaire

Group Type ACTIVE_COMPARATOR

Beer

Intervention Type DRUG

Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)

Videotaped drinking session

Intervention Type DEVICE

Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder

Non-elevated depressed mood

Lower score on Patient Health Questionnaire

Group Type ACTIVE_COMPARATOR

Beer

Intervention Type DRUG

Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)

Videotaped drinking session

Intervention Type DEVICE

Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder

Social Drinking status

The social drinker group will be those who consume alcohol regularly but with infrequent heavy drinking days.

Group Type ACTIVE_COMPARATOR

Beer

Intervention Type DRUG

Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)

Videotaped drinking session

Intervention Type DEVICE

Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder

Heavy drinker status

The heavy drinker group will be those who consume alcohol regularly with frequent heavy drinking days.

Group Type ACTIVE_COMPARATOR

Beer

Intervention Type DRUG

Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)

Videotaped drinking session

Intervention Type DEVICE

Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder

Interventions

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Beer

Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)

Intervention Type DRUG

Videotaped drinking session

Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder

Intervention Type DEVICE

Other Intervention Names

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video-assisted topography

Eligibility Criteria

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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

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Leeman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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EDGE Laboratory

Gainesville, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB201700455

Identifier Type: -

Identifier Source: org_study_id