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

Sponsor
University of Florida (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03314454
Collaborator
(none)
44
1
4
67.6
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Participants are aware of the interventions, but are not aware of the assigned arm.
Primary Purpose:
Other
Official Title:
Alcohol Use and Mental Health - Pilot Test of Video-assisted Drinking Topography
Actual Study Start Date :
Oct 12, 2017
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Potential of Alcohol Topography as Indicator of AUD [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 EDGE Laboratory Gainesville Florida United States 32611

    Sponsors and Collaborators

    • University of Florida

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT03314454
    Other Study ID Numbers:
    • IRB201700455
    First Posted:
    Oct 19, 2017
    Last Update Posted:
    Jun 13, 2022
    Last Verified:
    Jun 1, 2022
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 13, 2022