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

December 9, 2024 updated by: University of Florida
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • EDGE Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Elevated Mental Status
Elevated score on Patient Health Questionnaire
Drug: Beer
Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)
Device: Videotaped drinking session
Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder
Other Names:
  • video-assisted topography
Active Comparator: Non-elevated depressed mood
Lower score on Patient Health Questionnaire
Drug: Beer
Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)
Device: Videotaped drinking session
Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder
Other Names:
  • video-assisted topography
Active Comparator: Social Drinking status
The social drinker group will be those who consume alcohol regularly but with infrequent heavy drinking days.
Drug: Beer
Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)
Device: Videotaped drinking session
Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder
Other Names:
  • video-assisted topography
Active Comparator: Heavy drinker status
The heavy drinker group will be those who consume alcohol regularly with frequent heavy drinking days.
Drug: Beer
Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)
Device: Videotaped drinking session
Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder
Other Names:
  • video-assisted topography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Topography: Sip Frequency
Time Frame: 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
60 days (from phone screening to follow-up retest)
Alcohol Topography: Sip Interval
Time Frame: 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
60 days (from phone screening to follow-up retest)
Alcohol Topography: Sip Duration
Time Frame: 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
60 days (from phone screening to follow-up retest)
Alcohol Topography: Sip Amount.
Time Frame: 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
60 days (from phone screening to follow-up retest)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Robert Leeman, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2017

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201700455

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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