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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Driving Under the Influence
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: BAC Driving Feedback/Warning |
| No Feedback | Active comparator | Participants 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.
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)
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.
- First posted19 Apr 2018
- Study start2 Apr 2018
- Primary completion1 Jan 2019
- Study completion20 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Driving Under the InfluenceStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Denis McCarthy, University of Missouri-Columbia
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk for Alcohol Impaired Driving: From the Laboratory to the Natural Environment
- ClinicalTrials.gov ID
- NCT03503396
- Acronym / sponsor ID
- 2010187
- Conditions
- Driving Under the Influence
- Keywords
- drunk driving, alcohol impaired driving, drinking and driving, ambulatory assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Posted 3 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to either receive feedback from a breathalyzer device or to receive no information.
| Arm | Type | Receives |
|---|---|---|
| BAC feedback | Experimental | Behavioral: BAC Driving Feedback/WarningParticipants 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. |
| No Feedback | Active comparator | Behavioral: No FeedbackParticipants will not receive any information on their BAC from their device. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- no exclusion criteria other than failure to meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAC Driving Feedback/WarningParticipants will receive a warning at a set BAC limit, indicating they are too impaired to drive. | Behavioural | BAC feedback |
| No FeedbackParticipants will receive no information about BAC, but will still complete study assessments and provide breath samples during drinking sessions. | Behavioural | No Feedback |
Primary outcome
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.
1 secondary outcome
Perceived Risk of Driving After Drinking
Time frame: Self-reported current perception (i.e., "right now")
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.