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This was an internally-funded pilot and priority had to be given to grant-funded projects.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elevated Mental Status | Active Comparator | Elevated score on Patient Health Questionnaire |
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| Non-elevated depressed mood | Active Comparator | Lower score on Patient Health Questionnaire |
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| Social Drinking status | Active Comparator | The social drinker group will be those who consume alcohol regularly but with infrequent heavy drinking days. |
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| Heavy drinker status | Active Comparator | The heavy drinker group will be those who consume alcohol regularly with frequent heavy drinking days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beer | Drug | Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 60 days (from phone screening to follow-up retest) |
| 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 | 60 days (from phone screening to follow-up retest) |
| 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 | 60 days (from phone screening to follow-up retest) |
| 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 | 60 days (from phone screening to follow-up retest) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Leeman, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EDGE Laboratory | Gainesville | Florida | 32611 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm: Heavy Drinking Only With Elevated and Non-elevated Depressed Mood | We terminated this study early with only 10 of the projected 40 participants completing an alcohol administration laboratory session. We terminated the study 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 including only those with heavy drinking and both elevated and non-elevated depressed mood. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age range recruited for study |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Deviation | sips per drink | 60 days (from phone screening to follow-up retest) |
|
16 months
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 adverse events (of which there were none) among the full sample only
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 adverse events (of which there were none) among the full sample only |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Leeman | Northeastern University | 6173736501 | r.leeman@northeastern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2022 | Jun 16, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001515 | Beer |
| ID | Term |
|---|---|
| D000434 | Alcoholic Beverages |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Participants are aware of the interventions, but are not aware of the assigned arm.
| Videotaped drinking session | Device | Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder |
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| Count of Participants |
| Participants |
| No |
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| Sex: Female, Male | Self-reported sex at birth | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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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.
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| 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 | 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. | Posted | Mean | Standard Deviation | minutes | 60 days (from phone screening to follow-up retest) |
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| 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 | 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. | Posted | Mean | Standard Deviation | seconds | 60 days (from phone screening to follow-up retest) |
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| 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 | 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. | Posted | Mean | Standard Deviation | grams per sip | 60 days (from phone screening to follow-up retest) |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D000088082 |
| Fermented Beverages |
| D000074421 | Fermented Foods |
| D019602 | Food and Beverages |