Alcohol Use and Mental Health - Pilot Test of Video-assisted Drinking Topography
Primary Purpose
Alcohol Use Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Beer
Videotaped drinking session
Sponsored by
About this trial
This is an interventional other trial for Alcohol Use Disorder
Eligibility Criteria
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
Sites / Locations
- EDGE Laboratory
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Elevated Mental Status
Non-elevated depressed mood
Social Drinking status
Heavy drinker status
Arm Description
Elevated score on Patient Health Questionnaire
Lower score on Patient Health Questionnaire
The social drinker group will be those who consume alcohol regularly but with infrequent heavy drinking days.
The heavy drinker group will be those who consume alcohol regularly with frequent heavy drinking days.
Outcomes
Primary Outcome Measures
Potential of Alcohol Topography as Indicator of AUD
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03314454
Brief Title
Alcohol Use and Mental Health - Pilot Test of Video-assisted Drinking Topography
Official Title
Alcohol Use and Mental Health - Pilot Test of Video-assisted Drinking Topography
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants are aware of the interventions, but are not aware of the assigned arm.
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elevated Mental Status
Arm Type
Active Comparator
Arm Description
Elevated score on Patient Health Questionnaire
Arm Title
Non-elevated depressed mood
Arm Type
Active Comparator
Arm Description
Lower score on Patient Health Questionnaire
Arm Title
Social Drinking status
Arm Type
Active Comparator
Arm Description
The social drinker group will be those who consume alcohol regularly but with infrequent heavy drinking days.
Arm Title
Heavy drinker status
Arm Type
Active Comparator
Arm Description
The heavy drinker group will be those who consume alcohol regularly with frequent heavy drinking days.
Intervention Type
Drug
Intervention Name(s)
Beer
Intervention Description
Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)
Intervention Type
Device
Intervention Name(s)
Videotaped drinking session
Other Intervention Name(s)
video-assisted topography
Intervention Description
Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder
Primary Outcome Measure Information:
Title
Potential of Alcohol Topography as Indicator of AUD
Description
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.
Time Frame
60 days (from phone screening to follow-up retest)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Leeman, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
EDGE Laboratory
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Alcohol Use and Mental Health - Pilot Test of Video-assisted Drinking Topography
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