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Driving Under the InfluenceNCT03503396

Alcohol Impaired Driving in the Natural Environment

A study testing BAC Driving Feedback/Warning and No Feedback in people with Driving Under the Influence, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Driving Under the Influence
What is being tested?
BAC Driving Feedback/Warning and No Feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
2 Apr 2018to 20 Jan 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • no exclusion criteria other than failure to meet inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Missouri-Columbia

    Columbia, Missouri, 65211

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
BAC Driving Feedback/Warning, No Feedback
Keywords
drunk driving, alcohol impaired driving, drinking and driving, ambulatory assessment
Medical subject headings
Driving Under the Influence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAC Driving Feedback/WarningBehavioural

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

  • No FeedbackBehavioural

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

Study groups in NCT03503396
Study groupRoleWhat they receive
BAC feedbackExperimentalParticipants 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.
Receives: Behavioral: BAC Driving Feedback/Warning
No FeedbackActive comparatorParticipants will not receive any information on their BAC from their device.
Receives: Behavioral: No Feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (1)
  1. 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.

    Measured: Self-reported current perception (i.e., "right now")

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2018
  2. Study start2 Apr 2018
  3. Primary completion1 Jan 2019
  4. Study completion20 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be assigned to either receive feedback from a breathalyzer device or to receive no information.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03503396
Sponsor's protocol ID
2010187
Other IDs
R01AA019546-06A1
Status last verified
Apr 2023
First submitted
11 Apr 2018
Last updated
3 May 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BAC Driving Feedback/Warning and No Feedback in people with Driving Under the Influence, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alcohol Impaired Driving Behavior (time frame: Baseline (4 week prior to initial interview) and trial period (2 weeks after initial interview)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.

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