NCT03846050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

5.4 years

First QC Date

January 30, 2019

Last Update Submit

July 16, 2024

Conditions

Drinking and Driving

Keywords

alcohol impaired drivingdecision makingdrunk drivingambulatory assessment

Outcome Measures

Primary Outcomes (3)

  • Alcohol impaired driving behavior

    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)

    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

    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 Outcomes (1)

  • Perceived risk of driving

    6 weeks

Study Arms (3)

BAC Feedback, immediate onset

EXPERIMENTAL

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

BAC Feedback, delayed onset

EXPERIMENTAL

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

Minimal Assessment Control

PLACEBO COMPARATOR

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

Interventions

BAC feedback/warningBEHAVIORAL

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.

BAC Feedback, delayed onsetBAC Feedback, immediate onset
No BAC feedback/warningBEHAVIORAL

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

Minimal Assessment Control

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

Location

Related Publications (1)

  • Haney AM, Motschman CA, Warner OM, Wesley RL, Wycoff AM, Trull TJ, McCarthy DM. Comparing associations between mood and breath alcohol concentration in the laboratory and natural environment. Psychol Addict Behav. 2022 Nov;36(7):885-894. doi: 10.1037/adb0000814. Epub 2022 Feb 7.

    PMID: 35129995DERIVED

MeSH Terms

Conditions

Driving Under the Influence

Condition Hierarchy (Ancestors)

Criminal BehaviorBehaviorDangerous Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 19, 2019

Study Start

December 15, 2018

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

July 18, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)