N/A
N=20
Evaluating Perceived Fitness to Drive While Intoxicated
Alcohol Drinking · Alcohol Intoxication · Perception, Self · Drinking, Alcohol · Driving Under the Influence
Bottom Line
View on ClinicalTrials.gov: NCT05028413 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Participants' Perceived Fitness to Drive Measurement — 6.5; 4.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Participants Shown their Breath Alcohol Content Measurement (Behavioral)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants' Perceived Fitness to Drive Measurement |
6.5; 4.6 | — |
| SECONDARY Participants' Perceived Willingness to Drive Measurement |
3.5; 5.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT05028413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.