- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02841735
Young Adult Naturalistic Alcohol Study (YANAS) Using Smartphone Technology in a Simulated Laboratory Environment
November 29, 2018 updated by: University of Florida
It is important to explore use of technology to reduce drinking.
The purpose of this research study is to compare different types of mobile technology for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in four phases: a web-based screening assessment; brief appointment on the day of the alcohol drinking session; alcohol drinking session; and a follow-up appointment.
Participation in this study will last approximately two months.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
9
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Gainesville, Florida, United States, 32611
- Department of Health Education and Behavior
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Interested individuals will contact the study by telephone or by email or will go directly to the study's information page located at www.yanasinfo.org.
Description
Inclusion Criteria:
- Be able to read English and complete assessments
- Drink alcohol regularly
Exclusion Criteria:
- Test positive on a urine test for use of certain illegal drugs
- Undergraduate student enrolled in the University of Florida
- Graduate students from the College of Health and Human Performance at the University of Florida
- Pregnant, or breast feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Smartphone breathalyzer device & app
This is a small device that attaches to a smartphone with an accompanying app that produces accurate breath alcohol readings when a user blows into a small tube attached to the device.
Participants randomized to this study condition will have the opportunity to use this device and app during an alcohol drinking session in a simulated laboratory.
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Participants randomized to this condition will be able to blow into the smartphone breathalyzer after consuming each alcoholic drink, which produces an accurate breath alcohol reading on the app.
These breath alcohol readings may inform participants' subsequent decisions regarding drinking.
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BAC estimator app
This is an app that produces estimated blood alcohol content (eBAC) readings based on sex, weight, number of drinks and time taken to consume drinks.
Participants randomized to this study condition will have the opportunity to use this app during an alcohol drinking session in a simulated laboratory.
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Participants randomized to this condition will be able to make an entry into the BAC estimator app after consuming each alcoholic drink, which produces an estimated blood alcohol concentration based on the individual's sex, weight, number of alcoholic drinks and time spent drinking alcohol.
These estimated blood alcohol concentrations may inform participants' subsequent decisions regarding drinking.
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Text Messaging
A procedure whereby one sends a text message to the phone one is using after each alcoholic drink.
Participants randomized to this study condition will have the opportunity to the text messaging procedure during an alcohol drinking session in a simulated laboratory.
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Participants randomized to this condition will be instructed to send a text to a smartphone they will use for the study after each alcoholic drink.
A consideration of the number of texts sent may inform participants' subsequent decisions regarding drinking.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantity of alcohol consumption
Time Frame: During an alcohol drinking session
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Compare forms of mobile technology for their effects on alcohol consumption
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During an alcohol drinking session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert F. Leeman, Ph.D., University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Actual)
February 3, 2018
Study Completion (Actual)
February 3, 2018
Study Registration Dates
First Submitted
July 20, 2016
First Submitted That Met QC Criteria
July 20, 2016
First Posted (Estimate)
July 22, 2016
Study Record Updates
Last Update Posted (Actual)
December 3, 2018
Last Update Submitted That Met QC Criteria
November 29, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201500990
- ID00004419 (Other Grant/Funding Number: Health & Human Performance)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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