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Completed

NCT Number: NCT03846050

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.

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Key information

Conditions

Drinking and Driving Behavior Criminal Behavior Dangerous Behavior Driving Under the Influence

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAC feedback/warning

Behavioral

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.

No BAC feedback/warning

Behavioral

Participants will receive no information on their current intoxication and will be asked to report less information on their driving decisions.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Feb 19, 2019
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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