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Smartphone Technology: Young Adult Drinking (STEADY)

This study is currently recruiting participants.
Verified December 2016 by University of Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT02963818
First Posted: November 15, 2016
Last Update Posted: December 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Florida
  Purpose
Exploring technology based tools to reduce drinking is important. The purpose of this research study is to compare different BAC monitoring apps for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in six phases: a web-based and in-person screening assessment; brief counseling session on the day before the alcohol drinking session; brief appointment on the day of the alcohol drinking session; alcohol drinking session; two-week field period; and a follow-up appointment. Participation in this study will last approximately two months.

Condition Intervention Phase
Alcohol Use Alcohol Drinking Drinking Behavior Other: Smartphone breathalyzer device/app use Other: BAC estimator app use Other: Text messaging procedure Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Smartphone Technology Effects on Alcohol Drinking Among Young (STEADY) Adults Study

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Quantity of alcohol consumption [ Time Frame: During one alcohol drinking session, an average of 2 hours ]
    Compare forms of mobile technology for their effects on alcohol consumption


Secondary Outcome Measures:
  • Quantity of alcohol consumption [ Time Frame: two-week field period ]
    Compare forms of mobile technology for their effects on alcohol consumption


Estimated Enrollment: 99
Study Start Date: November 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smartphone breathalyzer device & app
This is a small device that connects 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 an actual bar and during a two-week field period.
Other: Smartphone breathalyzer device/app use
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.
Experimental: 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 an actual bar and during a two-week field period.
Other: BAC estimator app use
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.
Experimental: 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 an actual bar and during a two-week field period.
Other: Text messaging procedure
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be able to read/write English and complete study assessments
  • Drink alcohol regularly

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963818


Contacts
Contact: Benjamin L Berey, B.A. 352-296-1026 bberey@ufl.edu
Contact: Tessa M Frohe, B.A. 352-294-1026 tfrohe@ufl.edu

Locations
United States, Florida
EDGE Laboratory Recruiting
Gainesville, Florida, United States, 32611
Contact: EDGE Laboratory    352-214-4047    edgelab@hhp.ufl.edu   
Contact: Benjamin L Berey, B.A.    352-294-1026    bberey@ufl.edu   
Sponsors and Collaborators
University of Florida
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Robert F Leeman, Ph.D. University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02963818     History of Changes
Other Study ID Numbers: IRB201600614
R21AA023368 ( U.S. NIH Grant/Contract )
First Submitted: November 8, 2016
First Posted: November 15, 2016
Last Update Posted: December 19, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Florida:
Brief intervention
Harm reduction
Young adult
College Student

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs


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