Clinical trial NCT05028413: Evaluating Perceived Fitness to Drive While Intoxicated
Official title: Pilot Randomized Control Trial of Smartphone-enabled Breath Alcohol Monitoring on Perceived Fitness to Drive a Vehicle Among Intoxicated Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Alcohol Intoxication
Perception, Self
Drinking, Alcohol
Driving Under the Influence
Drinking Behavior
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Participants' Perceived Fitness to Drive Measurement
timeFrame: The duration of study visit, up to 8 hours
Secondary outcomes:
measure: Participants' Perceived Willingness to Drive Measurement
timeFrame: The duration of study visit, up to 8 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
Study officials:
References:
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