Evaluating Perceived Fitness to Drive While Intoxicated

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Randomized Control Trial of Smartphone-enabled Breath Alcohol Monitoring on Perceived Fitness to Drive a Vehicle Among Intoxicated Adults

Conditions
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Alcohol Drinking, Alcohol Intoxication, Perception, Self, Drinking, Alcohol, Driving Under the Influence, Drinking Behavior

Intervention / Treatment
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* Behavioral: Participants Shown their Breath Alcohol Content Measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Participants Blinded to BrAC reading (Control)<br>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. | |
| Experimental: Participants Aware of their BrAC reading<br>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. | Behavioral: Participants Shown their Breath Alcohol Content Measurement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 each Breath Alcohol Content Measurement collected | The duration of study visit, up to 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 each Breath Alcohol Content Measurement collected | The duration of study visit, up to 8 hours |