Alcohol Drinking, Alcohol Intoxication, Drinking, Alcohol, Drinking Behavior, Driving Under the Influence, Perception, Self
Conditions
Brief summary
The goal of this study is to conduct a laboratory-based pilot randomized control trial of smartphone-enabled breath alcohol monitoring on perceived fitness to drive a vehicle among intoxicated adults. The study team will enroll up to 30 adults aged \> 21-44 who are frequent drinkers without dependence who drive more than four times per week to complete a standardized alcohol drinking protocol in a monitored setting collecting breathalyzer measurements. The protocol involves consuming three weight-based doses of alcohol with a target BAC of 0.10 and completing breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. The control group will complete a visual analog scale on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro breathalyzer device, while the intervention group would do the same, but be shown their breath alcohol readings on the paired BACtrack smartphone application. The research team's previous research has validated the accuracy of the BACtrack Mobile Pro device to measure BAC within +/- 0.001 of police-grade breathalyzer and estimate BAC within +/- 0.01 of a blood test.
Interventions
BEHAVIORALParticipants 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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 21-39 years old, * Less than 4 drinking days and less than 12 drinks per week on average in the past 2 months, * Have consumed at least 4 (women) or 5 (men) drinks on one occasion, in the past year without experiencing adverse effects * Have a valid photo ID * Willing and able to use a rideshare credit or septa token as transportation home from the study visit * Drives at least 2 days per week on average.
Exclusion criteria
* Desire alcohol treatment now or received it in the past 6 months, * Have Alcohol use disorder per DSM-V criteria * Meet or have met criteria for a substance use disorder within the past 12 months per DSM V criteria * Have a prior psychiatric condition requiring hospitalization * Are non-English-speaking * Individuals who have a medical condition or who are taking medication which limits or prevents the consumption of alcohol * Are experiencing suicidal ideation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants' Perceived Fitness to Drive Measurement | The duration of study visit, up to 8 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants' Perceived Willingness to Drive Measurement | The duration of study visit, up to 8 hours | Participant'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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Participants Blinded to BrAC Reading (Control) | Participants Aware of Their BrAC Reading | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 25.7 years STANDARD_DEVIATION 4.2 | 28.5 years STANDARD_DEVIATION 4.2 | 27.1 years STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 10 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States Asian | 3 Participants | 0 Participants | 3 Participants |
| Region of Enrollment United States Black | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States White | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Participants' Perceived Fitness to Drive Measurement
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
Time frame: The duration of study visit, up to 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Blinded to BrAC Reading (Control) | Participants' Perceived Fitness to Drive Measurement | 6.5 units on a scale | Standard Deviation 2.5 |
| Participants Aware of Their BrAC Reading | Participants' Perceived Fitness to Drive Measurement | 4.6 units on a scale | Standard Deviation 1.9 |
Secondary
Participants' Perceived Willingness to Drive Measurement
Participant'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
Time frame: The duration of study visit, up to 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Blinded to BrAC Reading (Control) | Participants' Perceived Willingness to Drive Measurement | 3.5 units on a scale | Standard Deviation 2.3 |
| Participants Aware of Their BrAC Reading | Participants' Perceived Willingness to Drive Measurement | 5.5 units on a scale | Standard Deviation 2.5 |