Evaluating Perceived Fitness to Drive While Intoxicated (NCT05028413) | Clinical Trial Compass
CompletedNot Applicable
Evaluating Perceived Fitness to Drive While Intoxicated
United States22 participantsStarted 2017-05-08
Plain-language 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.
Who can participate
Age range
21 Years – 39 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants' Perceived Fitness to Drive Measurement
Timeframe: The duration of study visit, up to 8 hours