Evaluating Perceived Fitness to Drive While Intoxicated

NCT05028413 | Completed Results

• 1 other identifier: 827284
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Alcohol Intoxication; Perception, Self; Drinking, Alcohol; Driving Under the Influence; Drinking Behavior

Outcome Measures

Primary Outcomes (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

  The duration of study visit, up to 8 hours

Secondary Outcomes (1)

• Participants' Perceived Willingness to Drive Measurement

  The duration of study visit, up to 8 hours

Study Arms (2)

Participants Blinded to BrAC reading (Control)

NO INTERVENTION

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 Aware of their BrAC reading

EXPERIMENTAL

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

Interventions

Participants Shown their Breath Alcohol Content Measurement BEHAVIORAL

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 Aware of their BrAC reading

Eligibility Criteria

• Age: 21 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (7)

• 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.

  PMID: 18179312 BACKGROUND

• 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.

  PMID: 15907777 BACKGROUND

• 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.

  PMID: 23216417 BACKGROUND

• 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.

  PMID: 22690907 BACKGROUND

• 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.

  PMID: 8778124 BACKGROUND

• 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.

  PMID: 23596504 BACKGROUND

• 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.

  PMID: 40811123 DERIVED

Related Links

• BacTrack Mobile Smartphone Paired Breathalyzer

MeSH Terms

Conditions

Alcohol Drinking; Alcoholic Intoxication; Driving Under the Influence; Drinking Behavior

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Criminal Behavior; Dangerous Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Associate Professor Mucio C. Delgado, MD, MS
• Organization: University of Pennsylvania

mucio.delgado@pennmedicine.upenn.edu

215-74-826

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine and Epidemiology

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 31, 2021
• Study Start: May 8, 2017
• Primary Completion: June 23, 2017
• Study Completion: June 23, 2017
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)