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Clinical Trials/NCT03503396
NCT03503396CompletedNot Applicable

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

University of Missouri-Columbia1 site in 1 country48 target enrollmentStarted: April 2, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
Alcohol Impaired Driving Behavior

Study Overview

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.

Detailed Description

Despite previous success in reducing alcohol impaired driving (AID) and fatal crashes, rates have not decreased significantly since the 1990s. Developing novel approaches to prevention/intervention are likely required to produce further progress.

This project is designed to evaluate a potential intervention for AID using mobile technology. In addition, the project is designed to provide pilot data for a large scale investigation.

Recent laboratory work by the PI has demonstrated the utility of assessing AID risk factors when participants are intoxicated. We identified four risk factors that, measured under intoxication, are cross-sectional predictors of AID: AID attitudes (Morris et al., 2014), impulsivity (McCarthy et al., 2012), behavioral economic demand (Amlung et al., 2016) and subjective intoxication (Amlung et al., 2014).

The proposed project will evaluate these factors as prospective predictors of AID and extend this work outside the laboratory and into participants' natural drinking environment using Ambulatory Assessment (AA). AA is a set of techniques used to collect data from individuals in the course of their daily life. AA methods provide increased ecological validity across multiple modalities (e.g., self-report, physiological measures). No study to date has used AA to examine AID. We will employ a combination of three AA methods: ecological momentary assessment, geospatial technology, and portable breath analysis.

Ecological Momentary Assessment (EMA) is a form of AA that allows participants to self-report on their current thoughts, feelings, and behaviors in their natural environment (Shiffman et al., 2008). EMA avoids most pitfalls of retrospective reports, and is increasingly used to study temporally proximal influences on substance use behaviors (Shiffman, 2009). Despite the importance of such influences to AID decisions (Quinn & Fromme, 2012), no study to date has applied EMA methods to the study of AID.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •no exclusion criteria other than failure to meet inclusion criteria

Arms & Interventions

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.

Intervention: BAC Driving Feedback/Warning (Behavioral)

No Feedback

Active Comparator

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

Intervention: No Feedback (Behavioral)

Outcomes

Primary Outcomes

Alcohol Impaired Driving Behavior

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

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.

Secondary Outcomes

  • Perceived Risk of Driving After Drinking(Self-reported current perception (i.e., "right now"))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Denis McCarthy

Professor

University of Missouri-Columbia

Study Sites (1)

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