Alcohol Impaired Driving: From the Laboratory to the Natural Environment

July 16, 2024 updated by: Denis McCarthy, University of Missouri-Columbia

Risk for Alcohol Impaired Driving: From the Laboratory to the Natural Environment

This project combined laboratory and ambulatory assessment (AA) methods to test decision making associated with alcohol impaired driving (AID). Participants will complete a laboratory alcohol administration session followed by 6 weeks of mobile assessment. Data from drinking events will be examined to test how individuals make choices about driving or not after consuming alcohol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Building on laboratory findings from the the PI's (McCarthy) previous work, this project is designed to test AID decision making in both the lab and the natural drinking environment in which AID decisions are made.

Participants complete a laboratory alcohol administration session followed by six weeks of multi-method ambulatory assessment. The ambulatory assessment component will include participant report via smartphone, portable breathalizer (BACtrack), and location and movement data passively collected by the smartphone GPS/accelerometer. The combination of these methods will allow for the integration of subjective (e.g., perceived intoxication) and objective (e.g., BrAC, calculated drinking location) data for each drinking episode.

Aim 1 of the project is to test laboratory measures as prospective predictors of AID and examine the role of event-level influences on specific AID decisions.

Aim 2 of the proposed project is to test the potential for a novel intervention to reduce AID using mobile technology. Participants will be randomly assigned to either a full ambulatory assessment or a minimal assessment control condition. The timing of the introduction of AA will also be manipulated within the full ambulatory assessment condition. This design will allow us to test whether the introduction of ambulatory assessment produces changes in AID behavior, as well as whether such changes persist once ambulatory assessment is discontinued. Changes made to the revised application are aimed at ensuring the achievement of both study aims. If Aim 2 is achieved and ambulatory assessment alters AID behavior, the combination of the minimal assessment control condition and the full assessment condition prior to the introduction of ambulatory assessment has sufficient sample size and power to test Aim 1 hypotheses.

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

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

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri-Columbia

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 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • moderate to heavy drinkers must drive regularly report recent binge drinking fluent in english

Exclusion Criteria:

  • not in treatment for substance use disorder or other psychiatric disorders BMI under 30 no medical conditions contraindicating alcohol consumption

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BAC Feedback, immediate onset

Participants will receive a"BAC Feedback/Warning" intervention based on their assessed BAC. Participants in this arm will have a warning presented on their smartphone when they provide a breath sample that indicated their BAC has reached a set limit. The cutpoint for this warning is not disclosed but is well below the legal limit for driving. Warning will notify them that their results indicate it is not safe for them to drive.

In this condition, participants will start their 6 week AA portion of their participation immediately after their laboratory session, and will be followed for 6 weeks afterwards.

Comparisons between the two experimental conditions will allow for inferences about the onset and offset of any effects of the "BAC Feedback/Warning" intervention.
Behavioral: BAC feedback/warning
Participants will receive a warning when their BAC reaches a set limit. The cutpoint for this warning is not disclosed but is well below the legal limit for driving. Warning will notify them that their results indicate it is not safe for them to drive.
Experimental: BAC Feedback, delayed onset

Participants will receive the "BAC Feedback/Warning" intervention based on their assessed BAC during drinking events.The cutpoint for this warning is not disclosed but is well below the legal limit for driving. Warning will notify them that their results indicate it is not safe for them to drive.

In this condition, participants will be followed for 6 weeks after their laboratory session prior to starting their 6 week AA portion of their participation.

Comparisons between the two experimental conditions will allow for inferences about the onset and offset of any effects of the "BAC Feedback/Warning" intervention.
Behavioral: BAC feedback/warning
Participants will receive a warning when their BAC reaches a set limit. The cutpoint for this warning is not disclosed but is well below the legal limit for driving. Warning will notify them that their results indicate it is not safe for them to drive.
Placebo Comparator: Minimal Assessment Control

Participants will receive the "No BAC Feedback/Warning" intervention. Participants in this condition will complete the laboratory and interview portions of the project. However the AA portion of the project will not contain warning about their BAC (No BAC Feedback/Warning) and will ask fewer questions regarding their AID decisions.

The role of this condition is to provide a baseline comparison of AID behavior for the two active assessment conditions.
Behavioral: No BAC feedback/warning
Participants will receive no information on their current intoxication and will be asked to report less information on their driving decisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol impaired driving behavior
Time Frame: 12 weeks
Participants will provide self-reported driving behavior (yes/no driven a vehicle) after drinking alcohol during the AA portion. This assessment will be taken from their daily smartphone responses.
12 weeks
Alcohol impaired driving behavior (retrospective)
Time Frame: 12 weeks
Participants will provide self-reported driving behavior (yes/no driven a vehicle) after drinking alcohol retrospectively during interview sessions. Participants will complete regular phone interview where their daily driving and drinking behavior will be assessed. The outcome measure of interest will be days when participants report driving (yes/no) after consuming alcohol.
12 weeks
Alcohol impaired driving intentions
Time Frame: 6 weeks
Participants will provide self-reported intentions to drive after drinking alcohol (Would you drive now? Yes/no) from daily assessments during the AA portion of the project.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived risk of driving
Time Frame: 6 weeks
Participants will report their perceived risk of driving (1 to 4 scale, "Not Dangerous to Very Dangerous") given their current level of impairment during AA portion of project.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 15, 2018

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

February 15, 2019

First Posted (Actual)

February 19, 2019

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008051
  • R01AA019546 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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