NCT01595659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2015

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

3.7 years

First QC Date

May 5, 2012

Last Update Submit

January 23, 2018

Conditions

Keywords

RiskYoung driversAlcoholPassengersGender

Outcome Measures

Primary Outcomes (1)

  • Risky driving in a simulator

    within 1 hr after alcohol dose

Study Arms (3)

no alcohol and passenger

PLACEBO COMPARATOR

Blood alcohol concentration (BAC) = 0.00% and risk accepting or averse passenger

Behavioral: Passenger

low alcohol dose and passenger

EXPERIMENTAL

BAC = 0.02% and risk accepting or averse passenger

Behavioral: Passenger

moderate alcohol dose and passenger

EXPERIMENTAL

BAC = 0.05% and risk accepting or averse passenger

Behavioral: Passenger

Interventions

PassengerBEHAVIORAL

Driving with risk accepting or risk averse passenger

low alcohol dose and passengermoderate alcohol dose and passengerno alcohol and passenger

Eligibility Criteria

Age18 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • health problem that contraindicates participation
  • pregnant or breastfeeding
  • signs of problem drinking
  • positive BAC or recent drug use measured at arrival

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Sherbrooke

Longueuil, Quebec, J4K 0A8, Canada

Location

MeSH Terms

Conditions

Coitus

Interventions

nuclear passenger protein-1, S pombe

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Marie Claude Ouimet, Ph.D.

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 5, 2012

First Posted

May 10, 2012

Study Start

September 30, 2011

Primary Completion

June 3, 2015

Study Completion

June 3, 2015

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations