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Trial Outcomes & Findings for Alcohol Impaired Driving in the Natural Environment (NCT NCT03503396)

NCT ID: NCT03503396

Last Updated: 2023-05-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

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

Results posted on

2023-05-03

Participant Flow

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
24
24
Overall Study
COMPLETED
22
24
Overall Study
NOT COMPLETED
2
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alcohol Impaired Driving in the Natural Environment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
BAC Feedback
n=24 Participants
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.
No Feedback
n=24 Participants
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.
Total
n=48 Participants
Total of all reporting groups
Age, Continuous
22.75 years
n=5 Participants
22.66 years
n=7 Participants
22.71 years
n=5 Participants
Sex: Female, Male
Female
16 Participants
n=5 Participants
19 Participants
n=7 Participants
35 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
5 Participants
n=7 Participants
13 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants
n=5 Participants
24 Participants
n=7 Participants
48 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
White
21 Participants
n=5 Participants
17 Participants
n=7 Participants
38 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
24 Participants
n=5 Participants
24 Participants
n=7 Participants
48 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
BAC Feedback
n=24 Participants
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.
No Feedback
n=24 Participants
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.
Alcohol Impaired Driving Behavior
Baseline
67 Count of driving episodes after drinking
60 Count of driving episodes after drinking
Alcohol Impaired Driving Behavior
Trial period
36 Count of driving episodes after drinking
29 Count of driving episodes after drinking

SECONDARY outcome

Timeframe: Self-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.

Outcome measures

Outcome measures
Measure
BAC Feedback
n=23 Participants
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.
No Feedback
n=22 Participants
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.
Perceived Risk of Driving After Drinking
2.9176 score on a scale (1-10)
Interval 1.6895 to 4.1456
1.6705 score on a scale (1-10)
Interval 0.9651 to 2.3758

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks of study intervention

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks of study intervention

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.

Outcome measures

Outcome data not reported

Adverse Events

BAC Feedback

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Feedback

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Denis McCarthy

University of Missouri

Phone: 573-882-0426

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place