Alcohol Drinking Clinical Trial
— BESAFEOfficial title:
Pilot Trial Leveraging Smartphone-paired Breathalyzers and Loss- and Gain-framed Text Notifications for Reducing Drinking Driving
NCT number | NCT03335735 |
Other study ID # | 827345 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 21, 2017 |
Est. completion date | June 30, 2018 |
Verified date | August 2018 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project aims to demonstrate the feasibility of a scalable behavioral intervention using smartphone-paired breathalyzers and text message aimed at reducing drinking and driving among individuals who report heavy drinking. All participants receive a smartphone breathalyzer to provide feedback on their estimated blood alcohol level. The intervention compares loss- and gain-framed messages that make the consequences of drinking and driving more salient to standard messages not to drink and drive.
Status | Completed |
Enrollment | 58 |
Est. completion date | June 30, 2018 |
Est. primary completion date | April 9, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 39 Years |
Eligibility |
Inclusion Criteria: - Between the ages of 21-39 - Reports an average of one heavy drinking day (men more than five drinks, women more than four drinks) per week over the preceding 8 weeks - Has a valid photo identification (ID) - Are willing and able to use an Uber or Lyft or septa as transportation home - Drives four or more trips per week - Owns an Apple iPhone or Android smartphone Exclusion Criteria: - Desire for alcohol treatment now or have received alcohol treatment within the past 6 months - Alcohol use disorder rated as severe per DSM-V criteria - Non-English-speaking - Women who are pregnant - Individuals who should not consume alcohol due to a medical condition such as liver disease, cancer, and seizure disorders. Participants will be asked to answer yes if they have any disorder that their doctor has suggested that they should not drink alcohol. If they are unsure or say I don't know the investigators will ask them to speak with their doctor prior to participation. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure will be the change in proportion of breathalyzer measurements submitted with self-reported drinking episodes across groups. | baseline up to 8 weeks | ||
Secondary | Change in frequency of BACtrack monitoring within intervention group from baseline | baseline up to 8 weeks | ||
Secondary | Drinking and driving episodes in which their BAC via self-report or BAC measure is expected to be positive | To be assessed using a driving monitoring app passively running on participants' phones throughout the trial | baseline up to 8 weeks | |
Secondary | Changes in accuracy of BAC guess vs actual BAC measure with continued use (Does a participant become more accurate overtime in predicting what their BAC will be prior to measuring) | Participants are able to guess their BAC within the app before collecting the measurement. We will examine the changes in the accuracy of their guesses over time | baseline up to 8 weeks |
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