Clinical trial NCT03314454: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Alcohol Use Disorder
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Alcohol Topography: Sip Frequency
timeFrame: 60 days (from phone screening to follow-up retest)
measure: Alcohol Topography: Sip Interval
timeFrame: 60 days (from phone screening to follow-up retest)
measure: Alcohol Topography: Sip Duration
timeFrame: 60 days (from phone screening to follow-up retest)
measure: Alcohol Topography: Sip Amount.
timeFrame: 60 days (from phone screening to follow-up retest)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: EDGE Laboratory
state: Florida
Study officials:
affiliation: University of Florida
name: Robert Leeman, PhD
role: PRINCIPAL_INVESTIGATOR
References: