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Alcohol Impaired Driving: From the Laboratory to the Natural Environment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03846050
Enrollment
230
Registered
2019-02-19
Start date
2018-12-15
Completion date
2024-06-01
Last updated
2024-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drinking and Driving

Keywords

alcohol impaired driving, decision making, drunk driving, ambulatory assessment

Brief summary

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.

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.

Interventions

BEHAVIORALBAC 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.

BEHAVIORALNo BAC feedback/warning

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

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Participants are randomly assigned to 3 conditions, 2 active and one control condition. In the active conditions, participants will receive warning messages when their BAC reaches a set threshold that it is not safe for them to drive. The two Active conditions differ in the timing of their onset of the intervention. The control condition will not receive warning and will not report on their driving decision in the moment.

Eligibility

Sex/Gender
ALL
Age
21 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Alcohol impaired driving behavior12 weeksParticipants 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.
Alcohol impaired driving behavior (retrospective)12 weeksParticipants 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.
Alcohol impaired driving intentions6 weeksParticipants 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

MeasureTime frameDescription
Perceived risk of driving6 weeksParticipants 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026