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Alcohol DrinkingNCT05028413

Evaluating Perceived Fitness to Drive While Intoxicated

A study testing Participants Shown their Breath Alcohol Content Measurement in people with Alcohol Drinking and Alcohol Intoxication, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 39 yearsHealthy volunteers can take part
What is being tested?
Participants Shown their Breath Alcohol Content Measurement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
8 May 2017to 23 Jun 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 39 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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.

Being tested
Participants Shown their Breath Alcohol Content Measurement
Medical subject headings
Alcohol Drinking, Alcoholic Intoxication, Driving Under the Influence, Drinking Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Participants Shown their Breath Alcohol Content MeasurementBehavioural

    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.

Study groups in NCT05028413
Study groupRoleWhat they receive
Participants Blinded to BrAC reading (Control)No interventionParticipants 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 Aware of their BrAC readingExperimentalParticipants 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.
Receives: Behavioral: Participants Shown their Breath Alcohol Content Measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: The duration of study visit, up to 8 hours

Secondary outcomes (1)

  1. 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

    Measured: The duration of study visit, up to 8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2021
  2. Study start8 May 2017
  3. Primary completion23 Jun 2017
  4. Study completion23 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05028413
Sponsor's protocol ID
827284
Status last verified
Jun 2024
First submitted
24 Aug 2021
Last updated
1 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Harrison EL, Marczinski CA, Fillmore MT. Driver training conditions affect sensitivity to the impairing effects of alcohol on a simulated driving test [corrected]. Exp Clin Psychopharmacol. 2007 Dec;15(6):588-98. doi: 10.1037/1064-1297.15.6.588.

    PubMed 18179312

  • Harrison EL, Fillmore MT. Are bad drivers more impaired by alcohol? Sober driving precision predicts impairment from alcohol in a simulated driving task. Accid Anal Prev. 2005 Sep;37(5):882-9. doi: 10.1016/j.aap.2005.04.005.

    PubMed 15907777

  • Marczinski CA, Stamates AL. Artificial sweeteners versus regular mixers increase breath alcohol concentrations in male and female social drinkers. Alcohol Clin Exp Res. 2013 Apr;37(4):696-702. doi: 10.1111/acer.12039. Epub 2012 Dec 6.

    PubMed 23216417

  • McCarthy DM, Niculete ME, Treloar HR, Morris DH, Bartholow BD. Acute alcohol effects on impulsivity: associations with drinking and driving behavior. Addiction. 2012 Dec;107(12):2109-14. doi: 10.1111/j.1360-0443.2012.03974.x. Epub 2012 Aug 10.

    PubMed 22690907

  • Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995 Nov;51(6):768-74. doi: 10.1002/1097-4679(199511)51:63.0.co;2-1.

    PubMed 8778124

  • Senecal N, Wang T, Thompson E, Kable JW. Normative arguments from experts and peers reduce delay discounting. Judgm Decis Mak. 2012 Sep 1;7(5):568-589.

    PubMed 23596504

  • Ebert JP, Kranzler HR, Barnett IJ, Hemmons JE, Yan R, Spencer E, Delgado MK. Effect of smartphone breathalyzer feedback on willingness to drive in moderately intoxicated individuals: A randomized trial. Psychol Addict Behav. 2025 Nov;39(7):669-675. doi: 10.1037/adb0001088. Epub 2025 Aug 14.

    PubMed 40811123

Questions about this trial

What is this clinical trial studying?

A study testing Participants Shown their Breath Alcohol Content Measurement in people with Alcohol Drinking and Alcohol Intoxication, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants' Perceived Fitness to Drive Measurement (time frame: The duration of study visit, up to 8 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05028413, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

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