Alcohol Impaired Driving in the Natural Environment

NCT03503396 | Completed Results

• 2 other identifiers: 2010187R01AA019546-06A1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to set up a larger investigation examining predictors of the decision to drive after consuming alcohol. All participants will carry a study provided smartphone and breathalyzer device for the 2 week period of the study. The intervention is that participants are randomly assigned to one of 2 breathalyzer feedback conditions - one where they receive a warning that their results indicate they should not drive and one where they receive no feedback. The study is designed to provide information needed for a larger version with a similar protocol, but also to provide an initial test of project hypotheses as well.

Conditions

Driving Under the Influence

Keywords

drunk driving; alcohol impaired driving; drinking and driving; ambulatory assessment

Outcome Measures

Primary Outcomes (1)

• Alcohol Impaired Driving Behavior

  Change in number of times driven after drinking per week from pre (4 week TLFB) to post (2 week TLFB). A Timeline Followback (TLFB) is an interview where the participant self-reports their drinking behavior including: where they were drinking, how much they drank of what over what period of time, what location they went to next, how they got there.

  Baseline (4 week prior to initial interview) and trial period (2 weeks after initial interview)

Secondary Outcomes (1)

• Perceived Risk of Driving After Drinking

  Self-reported current perception (i.e., "right now")

Other Outcomes (2)

• Proximal Predictors of Impaired Driving

  2 weeks of study intervention

• Effect of Self-monitoring on AID Behavior and Perceptions

  2 weeks of study intervention

Study Arms (2)

BAC feedback

EXPERIMENTAL

Participants will receive a warning when their BAC is above a set limit (cutpoint is not disclosed by well below legal limit). Warning will notify them that their results indicate it is not safe for them to drive.

Behavioral: BAC Driving Feedback/Warning

No Feedback

ACTIVE COMPARATOR

Participants will not receive any information on their BAC from their device.

Behavioral: No Feedback

Interventions

BAC Driving Feedback/Warning BEHAVIORAL

Participants will receive a warning at a set BAC limit, indicating they are too impaired to drive.

BAC feedback

No Feedback BEHAVIORAL

Participants will receive no information about BAC, but will still complete study assessments and provide breath samples during drinking sessions.

No Feedback

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• moderate to heavy drinkers.
• must drive regularly (including driving for social events).
• report binge drinking (4/5 drinks in a 2 hour period) at least once in the past month
• fluent in english

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Driving Under the Influence

Condition Hierarchy (Ancestors)

Criminal Behavior; Behavior; Dangerous Behavior

Limitations and Caveats

Due to the relatively brief EMA data collection period in this pilot/feasibility study, few alcohol-impaired driving events occurred during the study period, and we instead focused on driving intentions as the primary outcome.

Results Point of Contact

• Title: Dr. Denis McCarthy
• Organization: University of Missouri

mccarthydm@missouri.edu

573-882-0426

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be assigned to either receive feedback from a breathalyzer device or to receive no information.

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 19, 2018
• Study Start: April 2, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 20, 2019
• Last Updated: May 3, 2023
• Results First Posted: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)