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Alcohol Impaired Driving in 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
NCT03503396
Enrollment
48
Registered
2018-04-19
Start date
2018-04-02
Completion date
2019-01-20
Last updated
2023-05-03

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

Conditions

Driving Under the Influence

Keywords

drunk driving, alcohol impaired driving, drinking and driving, ambulatory assessment

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. Advancements in mobile technology, such as global position systems (GPS) and portable breathalizers, allow for the collection of objective data on participant location and alcohol use in real-time. We will combine location data (e.g., drinking venue, distance from home) and in-the-moment breathalyzer data with self-report EMA data from each participant drinking episode. This combination will allow for a more complete assessment of event-level factors that contribute to AID decisions. This pilot project will test the hypothesis that temporally proximal measures of AID risk factors (subjective impairment, perceived risk) collected during a drinking episode will improve prediction of AID, over and above trait measures of AID risk factors. The pilot project will also test the potential for AA to function as an intervention for AID. In this pilot, participants will be randomly assigned to either receive some feedback from their breathalyzer (a warning that they have consumed too much to drive safely) or not to receive any feedback. Note that participants will not be told their BAC, due to potential risks of specific feedback (increased consumption, titrating drinking to drive at slightly below .08). Instead, feedback will be general (Your results indicate that you have drank too much to drive safely), and participants will not be aware of what BAC triggers these warnings. Comparisons of all participants AID behavior at baseline (from a Timeline Follow-back assessment) with their AID behavior during study participation will be used to test whether the increased self-monitoring of AA can alter AID decisions. In addition, comparisons between groups (feedback vs. none) will test for potential effects of BAC feedback on AID decisions. Support for these hypotheses could lead to novel, cost-effective interventions to reduce AID using mobile technology. This pilot will enroll 40 moderate-to-heavy drinking young adults. Participants will complete a brief laboratory session of AID risk measures, followed by two weeks of AA. They will be randomly assigned to one of two conditions (BAC feedback vs. none). Interview assessments of AID will be conducted at baseline and at the completion of AA assessments, with interviewers blind to condition.

Interventions

BEHAVIORALBAC Driving Feedback/Warning

Participants will receive a warning at a set BAC limit, indicating they are too impaired to drive.

BEHAVIORALNo Feedback

Participants will receive no information about BAC, but will still complete study assessments and provide breath samples during drinking sessions.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Participants will be assigned to either receive feedback from a breathalyzer device or to receive no information.

Eligibility

Sex/Gender
ALL
Age
21 Years to 30 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Alcohol Impaired Driving BehaviorBaseline (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

MeasureTime frameDescription
Perceived Risk of Driving After DrinkingSelf-reported current perception (i.e., right now)Rating of danger of driving after receiving warning. Participants were asked to rate the perceived dangerousness of driving during drinking episodes by asking them to indicate how dangerous you feel it would be for you to drive right now Responses are recorded on a 1 (not at all dangerous) to 10 (extremely dangerous) visual analogue scale.

Other

MeasureTime frameDescription
Proximal Predictors of Impaired Driving2 weeks of study interventionOutside of the intervention effect, observational data will be used to test hypotheses about proximal predictors of driving behavior.
Effect of Self-monitoring on AID Behavior and Perceptions2 weeks of study interventionOutside of the intervention effect, observational data will be used to test hypotheses about whether all participants report reduced driving after drinking and increase perceive risk of driving after drinking during the intervention period.

Countries

United States

Participant flow

Participants by arm

ArmCount
BAC Feedback
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. BAC Driving Feedback/Warning: Participants will receive a warning at a set BAC limit, indicating they are too impaired to drive.
24
No Feedback
Participants will not receive any information on their BAC from their device. No Feedback: Participants will receive no information about BAC, but will still complete study assessments and provide breath samples during drinking sessions.
24
Total48

Baseline characteristics

CharacteristicBAC FeedbackTotalNo Feedback
Age, Continuous22.75 years22.71 years22.66 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants48 Participants24 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants6 Participants4 Participants
Race (NIH/OMB)
More than one race
1 Participants4 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
21 Participants38 Participants17 Participants
Region of Enrollment
United States
24 Participants48 Participants24 Participants
Sex: Female, Male
Female
16 Participants35 Participants19 Participants
Sex: Female, Male
Male
8 Participants13 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 24
other
Total, other adverse events
0 / 240 / 24
serious
Total, serious adverse events
0 / 240 / 24

Outcome results

Primary

Alcohol Impaired Driving Behavior

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.

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

ArmMeasureGroupValue (NUMBER)
BAC FeedbackAlcohol Impaired Driving BehaviorBaseline67 Count of driving episodes after drinking
BAC FeedbackAlcohol Impaired Driving BehaviorTrial period36 Count of driving episodes after drinking
No FeedbackAlcohol Impaired Driving BehaviorBaseline60 Count of driving episodes after drinking
No FeedbackAlcohol Impaired Driving BehaviorTrial period29 Count of driving episodes after drinking
Secondary

Perceived Risk of Driving After Drinking

Rating of danger of driving after receiving warning. Participants were asked to rate the perceived dangerousness of driving during drinking episodes by asking them to indicate how dangerous you feel it would be for you to drive right now Responses are recorded on a 1 (not at all dangerous) to 10 (extremely dangerous) visual analogue scale.

Time frame: Self-reported current perception (i.e., right now)

ArmMeasureValue (MEAN)
BAC FeedbackPerceived Risk of Driving After Drinking2.9176 score on a scale (1-10)
No FeedbackPerceived Risk of Driving After Drinking1.6705 score on a scale (1-10)
Other Pre-specified

Effect of Self-monitoring on AID Behavior and Perceptions

Outside of the intervention effect, observational data will be used to test hypotheses about whether all participants report reduced driving after drinking and increase perceive risk of driving after drinking during the intervention period.

Time frame: 2 weeks of study intervention

Other Pre-specified

Proximal Predictors of Impaired Driving

Outside of the intervention effect, observational data will be used to test hypotheses about proximal predictors of driving behavior.

Time frame: 2 weeks of study intervention

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