An interventional study of Participants Shown their Breath Alcohol Content Measurement in Alcohol Drinking, Alcohol Intoxication and Perception, Self, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 21 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Other
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.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 22 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
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
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
| Milestone | Participants Blinded to BrAC Reading (Control) | Participants Aware of Their BrAC Reading |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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
| units on a scale | Participants Blinded to BrAC Reading (Control) | Participants Aware of Their BrAC Reading |
|---|---|---|
| Participants' Perceived Fitness to Drive Measurement | 6.5 ± 2.5 | 4.6 ± 1.9 |
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
| units on a scale | Participants Blinded to BrAC Reading (Control) | Participants Aware of Their BrAC Reading |
|---|---|---|
| Participants' Perceived Willingness to Drive Measurement | 3.5 ± 2.3 | 5.5 ± 2.5 |
Collected over 8 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants Blinded to BrAC Reading (Control) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Participants Aware of Their BrAC Reading | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
20 patients analyzed between the ages of 21 and 39 that have a driver's license and have consumed alcohol (4 or more drinks for a woman)/ ( or more drinks or men) in on driving occasion without any problems. Participants have not received alcohol treatment in the last 6 months, do not desire alcohol treatment, nor are pregnant or nursing.
| Age, Categorical(Participants) | Participants Blinded to BrAC Reading (Control) | Participants Aware of Their BrAC Reading | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Participants Blinded to BrAC Reading (Control) | Participants Aware of Their BrAC Reading | Total |
|---|---|---|---|
| Mean | 25.7 ± 4.2 | 28.5 ± 4.2 | 27.1 ± 4.6 |
| Sex: Female, Male(Participants) | Participants Blinded to BrAC Reading (Control) | Participants Aware of Their BrAC Reading | Total |
|---|---|---|---|
| Female | 3 | 5 | 8 |
| Male | 7 | 5 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Participants Blinded to BrAC Reading (Control) | Participants Aware of Their BrAC Reading | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 10 | 10 | 20 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Participants Blinded to BrAC Reading (Control) | Participants Aware of Their BrAC Reading | Total |
|---|---|---|---|
| United States — White | 7 | 9 | 16 |
| United States — Asian | 3 | 0 | 3 |
| United States — Black | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
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