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临床试验/NCT03314454
NCT03314454终止4 期

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

University of Florida1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年10月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
11
试验地点
1
主要终点
Alcohol Topography: Sip Frequency

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants are aware of the interventions, but are not aware of the assigned arm.

入排标准

年龄范围
21 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Elevated Mental Status

Active Comparator

Elevated score on Patient Health Questionnaire

干预措施: Beer (Drug)

Elevated Mental Status

Active Comparator

Elevated score on Patient Health Questionnaire

干预措施: Videotaped drinking session (Device)

Non-elevated depressed mood

Active Comparator

Lower score on Patient Health Questionnaire

干预措施: Beer (Drug)

Non-elevated depressed mood

Active Comparator

Lower score on Patient Health Questionnaire

干预措施: Videotaped drinking session (Device)

Social Drinking status

Active Comparator

The social drinker group will be those who consume alcohol regularly but with infrequent heavy drinking days.

干预措施: Beer (Drug)

Social Drinking status

Active Comparator

The social drinker group will be those who consume alcohol regularly but with infrequent heavy drinking days.

干预措施: Videotaped drinking session (Device)

Heavy drinker status

Active Comparator

The heavy drinker group will be those who consume alcohol regularly with frequent heavy drinking days.

干预措施: Beer (Drug)

Heavy drinker status

Active Comparator

The heavy drinker group will be those who consume alcohol regularly with frequent heavy drinking days.

干预措施: Videotaped drinking session (Device)

结局指标

主要结局

Alcohol Topography: Sip Frequency

时间窗: 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

时间窗: 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

时间窗: 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.

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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