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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02963818
Other study ID # IRB201600614-N
Secondary ID R21AA023368
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date November 2016
Est. completion date June 20, 2020

Study information

Verified date February 2024
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date June 20, 2020
Est. primary completion date June 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
United States EDGE Laboratory Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantity of alcohol consumption Compare forms of mobile technology for their effects on alcohol consumption During one alcohol drinking session, an average of 2 hours
Secondary Quantity of alcohol consumption Compare forms of mobile technology for their effects on alcohol consumption two-week field period
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