Accidents, TrafficNCT01595659
Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults
A study testing Passenger in people with Accidents, Traffic, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidents, Traffic
- What is being tested?
- Passenger
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2011to 3 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- health problem that contraindicates participation
- pregnant or breastfeeding
- signs of problem drinking
- positive BAC or recent drug use measured at arrival
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Accidents, Traffic
- Being tested
- Passenger
- Keywords
- Risk, Young drivers, Alcohol, Passengers, Gender
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PassengerBehavioural
Driving with risk accepting or risk averse passenger
| Study group | Role | What they receive |
|---|---|---|
| no alcohol and passenger | Placebo comparator | Blood alcohol concentration (BAC) = 0.00% and risk accepting or averse passenger Receives: Behavioral: Passenger |
| low alcohol dose and passenger | Experimental | BAC = 0.02% and risk accepting or averse passenger Receives: Behavioral: Passenger |
| moderate alcohol dose and passenger | Experimental | BAC = 0.05% and risk accepting or averse passenger Receives: Behavioral: Passenger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risky driving in a simulator
Measured: within 1 hr after alcohol dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study start30 Sep 2011
- Primary completion3 Jun 2015
- Study completion3 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidents, TrafficStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Claude Ouimet, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Investigators
- Marie Claude Ouimet, Ph.D., Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595659
- Sponsor's protocol ID
- MOP-111034
- Status last verified
- Jan 2018
- First submitted
- 5 May 2012
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults
- ClinicalTrials.gov ID
- NCT01595659
- Acronym / sponsor ID
- MOP-111034
- Conditions
- Accidents, Traffic
- Keywords
- Risk, Young drivers, Alcohol, Passengers, Gender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Study start
- 30 Sep 2011 (actual)
- Primary completion
- 3 Jun 2015 (actual)
- Study completion
- 3 Jun 2015 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no alcohol and passenger | Placebo comparator | Behavioral: PassengerBlood alcohol concentration (BAC) = 0.00% and risk accepting or averse passenger |
| low alcohol dose and passenger | Experimental | Behavioral: PassengerBAC = 0.02% and risk accepting or averse passenger |
| moderate alcohol dose and passenger | Experimental | Behavioral: PassengerBAC = 0.05% and risk accepting or averse passenger |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- health problem that contraindicates participation
- pregnant or breastfeeding
- signs of problem drinking
- positive BAC or recent drug use measured at arrival
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PassengerDriving with risk accepting or risk averse passenger | Behavioural | low alcohol dose and passenger, moderate alcohol dose and passenger, no alcohol and passenger |
Primary outcome
Risky driving in a simulator
Time frame: within 1 hr after alcohol dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Claude Ouimet, Ph.D. principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passenger in people with Accidents, Traffic, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risky driving in a simulator (time frame: within 1 hr after alcohol dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.