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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05028413
Other study ID # 827284
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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