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

• ClinicalTrials.gov Identifier: NCT01595659
• Recruitment Status: Completed
• First Posted: May 10, 2012
• Last Update Posted: January 25, 2018
• Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Information provided by (Responsible Party): Marie Claude Ouimet, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Tracking Information

• First Submitted Date: May 5, 2012
• First Posted Date: May 10, 2012
• Last Update Posted Date: January 25, 2018
• Actual Study Start Date: September 30, 2011
• Actual Primary Completion Date: June 3, 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 8, 2012): Risky driving in a simulator [ Time Frame: within 1 hr after alcohol dose ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Accidents, Traffic

Intervention

Behavioral: Passenger

Driving with risk accepting or risk averse passenger

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 23, 2018): 240
• Original Estimated Enrollment (submitted: May 8, 2012): 200
• Actual Study Completion Date: June 3, 2015
• Actual Primary Completion Date: June 3, 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 21 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01595659
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Marie Claude Ouimet, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Study Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Collaborators: Not Provided

Investigators

• 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