Alcohol Use Disorder
Conditions
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.
Interventions
DRUGBeer
Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)
DEVICEVideotaped drinking session
Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants are aware of the interventions, but are not aware of the assigned arm.
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
We did not get far enough along with recruitment for this pilot study to recruit social drinkers, nor individuals with elevated mental status thus all participants recruited were considered to have heavy drinker status with non-elevated depressed mood, thus precluding comparisons between these groups.
Pre-assignment details
As explained in recruitment details, enrollment for this pilot study ended early before social drinkers or participants with elevated mental status could be recruited, thus precluding group comparisons.
Participants by arm
| Arm | Count |
|---|---|
| Study Sample We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Study Sample |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Race/Ethnicity, Customized Race/ethnicity Asian, non-Hispanic | 1 Participants |
| Race/Ethnicity, Customized Race/ethnicity Black, non-Hispanic | 2 Participants |
| Race/Ethnicity, Customized Race/ethnicity White, non-Hispanic | 7 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Alcohol Topography: Sip Amount.
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
Time frame: 60 days (from phone screening to follow-up retest)
Population: We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Sample | Alcohol Topography: Sip Amount. | 32.35 grams per sip | Standard Deviation 19.84 |
Primary
Alcohol Topography: Sip Duration
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
Time frame: 60 days (from phone screening to follow-up retest)
Population: We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Sample | Alcohol Topography: Sip Duration | 2.01 seconds | Standard Deviation 0.43 |
Primary
Alcohol Topography: Sip Frequency
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
Time frame: 60 days (from phone screening to follow-up retest)
Population: We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Sample | Alcohol Topography: Sip Frequency | 14.67 sips per drink | Standard Deviation 7.57 |
Primary
Alcohol Topography: Sip Interval
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
Time frame: 60 days (from phone screening to follow-up retest)
Population: We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Sample | Alcohol Topography: Sip Interval | 1.46 minutes | Standard Deviation 1.03 |