Drinking and DrivingNCT03846050
Alcohol Impaired Driving: From the Laboratory to the Natural Environment
A study testing BAC feedback/warning and No BAC feedback/warning in people with Drinking and Driving, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Drinking and Driving
- What is being tested?
- BAC feedback/warning and No BAC feedback/warning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2018to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- moderate to heavy drinkers must drive regularly report recent binge drinking fluent in english
Who cannot join
- not in treatment for substance use disorder or other psychiatric disorders BMI under 30 no medical conditions contraindicating alcohol consumption
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 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.
Read the detailed description
Building on laboratory findings from the the PI's (McCarthy) previous work, this project is designed to test AID decision making in both the lab and the natural drinking environment in which AID decisions are made.
Participants complete a laboratory alcohol administration session followed by six weeks of multi-method ambulatory assessment. The ambulatory assessment component will include participant report via smartphone, portable breathalizer (BACtrack), and location and movement data passively collected by the smartphone GPS/accelerometer. The combination of these methods will allow for the integration of subjective (e.g., perceived intoxication) and objective (e.g., BrAC, calculated drinking location) data for each drinking episode.
Aim 1 of the project is to test laboratory measures as prospective predictors of AID and examine the role of event-level influences on specific AID decisions.
Aim 2 of the proposed project is to test the potential for a novel intervention to reduce AID using mobile technology. Participants will be randomly assigned to either a full ambulatory assessment or a minimal assessment control condition. The timing of the introduction of AA will also be manipulated within the full ambulatory assessment condition. This design will allow us to test whether the introduction of ambulatory assessment produces changes in AID behavior, as well as whether such changes persist once ambulatory assessment is discontinued. Changes made to the revised application are aimed at ensuring the achievement of both study aims. If Aim 2 is achieved and ambulatory assessment alters AID behavior, the combination of the minimal assessment control condition and the full assessment condition prior to the introduction of ambulatory assessment has sufficient sample size and power to test Aim 1 hypotheses.
- Conditions
- Drinking and Driving
- Being tested
- BAC feedback/warning, No BAC feedback/warning
- Keywords
- alcohol impaired driving, decision making, drunk 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 feedback/warningBehavioural
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.
No BAC feedback/warningBehavioural
Participants will receive no information on their current intoxication and will be asked to report less information on their driving decisions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: No BAC feedback/warning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (1)
Perceived risk of driving
Participants will report their perceived risk of driving (1 to 4 scale, "Not Dangerous to Very Dangerous") given their current level of impairment during AA portion of project.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start15 Dec 2018
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drinking and DrivingStudies 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
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 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
- NCT03846050
- Sponsor's protocol ID
- 2008051
- Other IDs
- R01AA019546
- Status last verified
- Jul 2024
- First submitted
- 30 Jan 2019
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Darmour CA, Benvenuti MC, Stork JG, Hough TM, McCarthy DM. Within-Person and Between-Person Risk Perceptions Predict Driving After Drinking: An Ecological Momentary Assessment Study. Alcohol Clin Exp Res (Hoboken). 2026 Jun;50(6):e70355. doi: 10.1111/acer.70355.
PubMed 42281262Haney 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.
PubMed 35129995
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. 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
- NCT03846050
- Acronym / sponsor ID
- 2008051
- Conditions
- Drinking and Driving
- Keywords
- alcohol impaired driving, decision making, drunk driving, ambulatory assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Building on laboratory findings from the the PI's (McCarthy) previous work, this project is designed to test AID decision making in both the lab and the natural drinking environment in which AID decisions are made.
Participants complete a laboratory alcohol administration session followed by six weeks of multi-method ambulatory assessment. The ambulatory assessment component will include participant report via smartphone, portable breathalizer (BACtrack), and location and movement data passively collected by the smartphone GPS/accelerometer. The combination of these methods will allow for the integration of subjective (e.g., perceived intoxication) and objective (e.g., BrAC, calculated drinking location) data for each drinking episode.
Aim 1 of the project is to test laboratory measures as prospective predictors of AID and examine the role of event-level influences on specific AID decisions.
Aim 2 of the proposed project is to test the potential for a novel intervention to reduce AID using mobile technology. Participants will be randomly assigned to either a full ambulatory assessment or a minimal assessment control condition. The timing of the introduction of AA will also be manipulated within the full ambulatory assessment condition. This design will allow us to test whether the introduction of ambulatory assessment produces changes in AID behavior, as well as whether such changes persist once ambulatory assessment is discontinued. Changes made to the revised application are aimed at ensuring the achievement of both study aims. If Aim 2 is achieved and ambulatory assessment alters AID behavior, the combination of the minimal assessment control condition and the full assessment condition prior to the introduction of ambulatory assessment has sufficient sample size and power to test Aim 1 hypotheses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| BAC Feedback, immediate onset | Experimental | Behavioral: BAC feedback/warningParticipants 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. |
| BAC Feedback, delayed onset | Experimental | Behavioral: BAC feedback/warningParticipants 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. |
| Minimal Assessment Control | Placebo comparator | Behavioral: No BAC feedback/warningParticipants 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. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- moderate to heavy drinkers must drive regularly report recent binge drinking fluent in english
Key exclusion criteria (1 listed)
- not in treatment for substance use disorder or other psychiatric disorders BMI under 30 no medical conditions contraindicating alcohol consumption
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 feedback/warningParticipants 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. | Behavioural | BAC Feedback, delayed onset, BAC Feedback, immediate onset |
| No BAC feedback/warningParticipants will receive no information on their current intoxication and will be asked to report less information on their driving decisions. | Behavioural | Minimal Assessment Control |
Primary outcome
Alcohol impaired driving behavior
Time frame: 12 weeks
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.
Alcohol impaired driving behavior (retrospective)
Time frame: 12 weeks
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.
Alcohol impaired driving intentions
Time frame: 6 weeks
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.
1 secondary outcome
Perceived risk of driving
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Derived from this study: PubMed 42281262Darmour CA, Benvenuti MC, Stork JG, Hough TM, McCarthy DM. Within-Person and Between-Person Risk Perceptions Predict Driving After Drinking: An Ecological Momentary Assessment Study. Alcohol Clin Exp Res (Hoboken). 2026 Jun;50(6):e70355. doi: 10.1111/acer.70355.
- Derived from this study: PubMed 35129995Haney 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.
- Individual participant dataSharing planned: No
Related trials for Drinking and Driving
Recruiting
Evaluation of Global Smart Drinking Goals Initiative
Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms
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 feedback/warning and No BAC feedback/warning in people with Drinking and Driving, 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 1 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 18 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03846050, which also lists 2 linked publications.
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 18 Jul 2024.