Evaluating Perceived Fitness to Drive While Intoxicated

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05028413
• Other study ID #: 827284
• Status: Completed
• Phase: N/A
• Start date: May 8, 2017
• Est. completion date: June 23, 2017

Study information

• Verified date: January 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 23, 2017
• Est. primary completion date: June 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Intoxication
• Alcoholic Intoxication
• Drinking Behavior
• Drinking, Alcohol
• Driving Under the Influence
• Perception, Self

Intervention

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.

Locations

Country	Name	City	State
United States	Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. Erratum in: Exp Clin Psychopharmacol. 2008 Apr;16(2):177. — View Citation

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. — View Citation

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. — View Citation

Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995 Nov;51(6):768-74. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 each Breath Alcohol Content Measurement collected	The duration of study visit, up to 8 hours
Secondary	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 each Breath Alcohol Content Measurement collected	The duration of study visit, up to 8 hours

External Links

•   BacTrack Mobile Smartphone Paired Breathalyzer