- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01595659
Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults
January 23, 2018 updated by: Marie Claude Ouimet, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Longueuil, Quebec, Canada, J4K 0A8
- Université de Sherbrooke
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 21 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: no alcohol and passenger
Blood alcohol concentration (BAC) = 0.00% and risk accepting or averse passenger
|
Driving with risk accepting or risk averse passenger
|
Experimental: low alcohol dose and passenger
BAC = 0.02% and risk accepting or averse passenger
|
Driving with risk accepting or risk averse passenger
|
Experimental: moderate alcohol dose and passenger
BAC = 0.05% and risk accepting or averse passenger
|
Driving with risk accepting or risk averse passenger
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Risky driving in a simulator
Time Frame: within 1 hr after alcohol dose
|
within 1 hr after alcohol dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marie Claude Ouimet, Ph.D., Université de Sherbrooke
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2011
Primary Completion (Actual)
June 3, 2015
Study Completion (Actual)
June 3, 2015
Study Registration Dates
First Submitted
May 5, 2012
First Submitted That Met QC Criteria
May 8, 2012
First Posted (Estimate)
May 10, 2012
Study Record Updates
Last Update Posted (Actual)
January 25, 2018
Last Update Submitted That Met QC Criteria
January 23, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MOP-111034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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