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Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01595659
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Marie Claude Ouimet, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Tracking Information
First Submitted Date  ICMJE May 5, 2012
First Posted Date  ICMJE May 10, 2012
Last Update Posted Date January 25, 2018
Actual Study Start Date  ICMJE September 30, 2011
Actual Primary Completion Date June 3, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
Risky driving in a simulator [ Time Frame: within 1 hr after alcohol dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01595659 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults
Official Title  ICMJE Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults
Brief Summary Among the many risk factors that contribute to young drivers' crash involvement, two are critical: peer passenger presence, which is unique to young drivers, and the influence of alcohol, a universal risk for drivers but one against which young drivers are most susceptible. Clarification of how passenger presence interacts with alcohol consumption to increase risk is needed. The impact of experimentally manipulated passenger characteristics and alcohol quantity on risky driving is observed using driving simulation and a random assignment experimental design with a sample of 18-21 year old male and female drivers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Accidents, Traffic
Intervention  ICMJE Behavioral: Passenger
Driving with risk accepting or risk averse passenger
Study Arms  ICMJE
  • Placebo Comparator: no alcohol and passenger
    Blood alcohol concentration (BAC) = 0.00% and risk accepting or averse passenger
    Intervention: Behavioral: Passenger
  • Experimental: low alcohol dose and passenger
    BAC = 0.02% and risk accepting or averse passenger
    Intervention: Behavioral: Passenger
  • Experimental: moderate alcohol dose and passenger
    BAC = 0.05% and risk accepting or averse passenger
    Intervention: Behavioral: Passenger
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2018)
240
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2012)
200
Actual Study Completion Date  ICMJE June 3, 2015
Actual Primary Completion Date June 3, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • being 18 to 21 years of age (18 years old is the legal age for alcohol consumption in the province of Quebec)
  • past experirence with drinking at least 2 alcoholic beverages in one episode
  • having a provisional driving license
  • driving in the past 3 months

Exclusion Criteria:

  • health problem that contraindicates participation
  • pregnant or breastfeeding
  • signs of problem drinking
  • positive BAC or recent drug use measured at arrival
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 21 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595659
Other Study ID Numbers  ICMJE MOP-111034
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marie Claude Ouimet, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Study Sponsor  ICMJE Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie Claude Ouimet, Ph.D. Université de Sherbrooke
PRS Account Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP