Trial Outcomes & Findings for Evaluating Perceived Fitness to Drive While Intoxicated (NCT NCT05028413)
NCT ID: NCT05028413
Last Updated: 2024-10-01
Results Overview
Participant's self rating on visual analog scale from 1-10 (1: Extremely Able to Drive; 10: Not at all Able to Drive) after Breath Alcohol Content Measurement was collected
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
The duration of study visit, up to 8 hours
Results posted on
2024-10-01
Participant Flow
Participant milestones
| Measure |
Participants Blinded to BrAC Reading (Control)
Participants randomized to this arm will consume three weight-based doses of alcohol with a target BAC of 0.10 and comple breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. They will complete a visual analog scale (the Self-Reported intoxication Survey) on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro device.
|
Participants Aware of Their BrAC Reading
Participants randomized to this arm will consume three weight-based doses of alcohol with a target BAC of 0.10 and comple breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. They will be shown their breath alcohol readings with the BACtrack Mobile Pro device before completing a visual analog scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.
Participants Shown their Breath Alcohol Content Measurement: Each time a Breath Alcohol Content (BrAC) Measurement is taken by the research team, the participant is shown the measurement before completing the paper visual analog scale scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Perceived Fitness to Drive While Intoxicated
Baseline characteristics by cohort
| Measure |
Participants Blinded to BrAC Reading (Control)
n=10 Participants
Participants randomized to this arm will consume three weight-based doses of alcohol with a target BAC of 0.10 and comple breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. They will complete a visual analog scale (the Self-Reported intoxication Survey) on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro device.
|
Participants Aware of Their BrAC Reading
n=10 Participants
Participants randomized to this arm will consume three weight-based doses of alcohol with a target BAC of 0.10 and comple breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. They will be shown their breath alcohol readings with the BACtrack Mobile Pro device before completing a visual analog scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.
Participants Shown their Breath Alcohol Content Measurement: Each time a Breath Alcohol Content (BrAC) Measurement is taken by the research team, the participant is shown the measurement before completing the paper visual analog scale scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.7 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
28.5 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
27.1 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 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
|
|
Region of Enrollment
United States · White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The duration of study visit, up to 8 hoursParticipant's self rating on visual analog scale from 1-10 (1: Extremely Able to Drive; 10: Not at all Able to Drive) after Breath Alcohol Content Measurement was collected
Outcome measures
| Measure |
Participants Blinded to BrAC Reading (Control)
n=10 Participants
Participants randomized to this arm will consume three weight-based doses of alcohol with a target BAC of 0.10 and comple breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. They will complete a visual analog scale (the Self-Reported intoxication Survey) on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro device.
|
Participants Aware of Their BrAC Reading
n=10 Participants
Participants randomized to this arm will consume three weight-based doses of alcohol with a target BAC of 0.10 and comple breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. They will be shown their breath alcohol readings with the BACtrack Mobile Pro device before completing a visual analog scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.
Participants Shown their Breath Alcohol Content Measurement: Each time a Breath Alcohol Content (BrAC) Measurement is taken by the research team, the participant is shown the measurement before completing the paper visual analog scale scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.
|
|---|---|---|
|
Participants' Perceived Fitness to Drive Measurement
|
6.5 units on a scale
Standard Deviation 2.5
|
4.6 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: The duration of study visit, up to 8 hoursParticipant's self rating on visual analog scale from 1-10 (1: Not at all Willing to Drive; 10: Extremely Willing to Drive) after Breath Alcohol Content Measurement was collected
Outcome measures
| Measure |
Participants Blinded to BrAC Reading (Control)
n=10 Participants
Participants randomized to this arm will consume three weight-based doses of alcohol with a target BAC of 0.10 and comple breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. They will complete a visual analog scale (the Self-Reported intoxication Survey) on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro device.
|
Participants Aware of Their BrAC Reading
n=10 Participants
Participants randomized to this arm will consume three weight-based doses of alcohol with a target BAC of 0.10 and comple breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. They will be shown their breath alcohol readings with the BACtrack Mobile Pro device before completing a visual analog scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.
Participants Shown their Breath Alcohol Content Measurement: Each time a Breath Alcohol Content (BrAC) Measurement is taken by the research team, the participant is shown the measurement before completing the paper visual analog scale scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.
|
|---|---|---|
|
Participants' Perceived Willingness to Drive Measurement
|
3.5 units on a scale
Standard Deviation 2.3
|
5.5 units on a scale
Standard Deviation 2.5
|
Adverse Events
Participants Blinded to BrAC Reading (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants Aware of Their BrAC Reading
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
Associate Professor Mucio C. Delgado, MD, MS
University of Pennsylvania
Phone: 215-74-826
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place