Psychomotor ImpairmentNCT02710578
Alcohol Effects on Driving-related Skills of Young Drivers
A study testing Alcohol in people with Psychomotor Impairment, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Given the known driving behavior of Driving Under the Influence of Alcohol and some of its parallel to driving under the influence of cannabis, this supplemental study aims to validate the sensitivity of the primary and secondary outcome measures employed in a cannabis and driving study currently in progress. Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychomotor Impairment
- What is being tested?
- Alcohol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to 18 Jul 2017
- 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 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females aged 19 to 25.
- Reported consumption of at least 1 heavy drinking episode (according to NIAAA criteria of 5 drinks for males and 4 for females within an occasion) in the 6 months prior to eligibility assessment.
- Held a valid class G or G2 Ontario driver's license (or equivalent from another jurisdiction) for at least 12 months.
- Willing to abstain from alcohol use for the duration of the study, and for 48 hours prior to Session 2.
- Provides written and informed consent.
Who cannot join
- Taking medications or have any medical condition for which alcohol is contraindicated
- Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants).
- Diagnosis of severe medical or psychiatric conditions.
- Meets criteria for current or lifetime Substance Use Disorders (DSM-IV) with the exception of nicotine.
- Meets criteria for Alcohol Dependence (DSM-IV)
- Is pregnant, is trying to become pregnant, or is currently breastfeeding.
- Severe allergic reaction to citrus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute and Residual Effects of Alcohol on Young Drivers' Performance of Driving Related Skills
Given the known driving behavior of Driving Under the Influence of Alcohol and some of its parallel to driving under the influence of cannabis, this supplemental study aims to validate the sensitivity of the primary and secondary outcome measures employed in a cannabis and driving study currently in progress.
Read the detailed description
This study will examine the effects of an intoxicating dose of alcohol on driving-related skills among young drivers using driving simulator technology.
This study is a double-blind, placebo-controlled mixed design study, including randomized between-subjects comparison of the effects of alcohol intoxication and both between- and within-subjects examination of acute and residual effects at approximately 24 and 48 hours following one-time alcohol administration.
Initial contact with potential participants will be made by telephone, where study personnel will conduct a telephone screen for eligibility. Those telephone screened as eligible will attend CAMH for an eligibility assessment. Enrolled participants will complete four sessions on consecutive days: a practice day, an alcohol administration day, and a 24-hour and 48-hour post-alcohol session.
- Conditions
- Psychomotor Impairment
- Being tested
- Alcohol, Placebo
- Keywords
- Alcohol impaired driving, Driving simulation, Residual effects of alcohol, Acute psychomotor effects of alcohol, Young drivers
- Medical subject headings
- Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
Also called Smirnoff Vodka
A single oral administration of an alcoholic beverage mixed in a 1:3 ratio of alcohol (Vodka) to tonic water to obtain a target BAC of 0.08mg%
PlaceboDrug
Also called Tonic water
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol | Active comparator | Alcohol Receives: Drug: Alcohol |
| Placebo | Placebo comparator | Tonic water Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor impairment (driving)
The driving simulator will objectively measure changes in driving behaviour after drinking alcohol.
Measured: Approximate Time Frame: 30 minutes before, 30 minutes after, 24 and 48 hours after drinking
Secondary outcomes (3)
Subjective alcohol effects
Visual analogue scale measures how participants feel before and after drinking alcohol. administration.
Measured: Approximate Time Frame: 30 minutes before drinking, 5, 15, 30 minutes and 1, 2, 3, 24 and 48 hours post-drinking
Cognitive testing
Changes in Continuous Performance Test performance.
Measured: Approximate Time Frame: 30 minutes before drinking, and 1, 24 and 48 hours post-drinking
Breath alcohol content (BAC)
Changes in BAC after drinking
Measured: Approximate Time Frame: 30 minutes before drinking, 5, 15, 30, minutes and 1, 2, 3, 24, and 48 hours post-drinking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion18 Jul 2017
- Study completion18 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychomotor ImpairmentStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Transportation
- Responsible party
- Principal investigator, Robert Mann, Centre for Addiction and Mental Health
- Investigators
- Robert Mann, PhD, Principal investigator, Centre for Addiction and Mental HealthBernard Le Foll, MD, PhD, Principal investigator, Centre for Addiction and Mental HealthBruna Brands, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710578
- Sponsor's protocol ID
- 114/2014
- Status last verified
- Jan 2019
- First submitted
- 2 Feb 2016
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lenne MG, Dietze PM, Triggs TJ, Walmsley S, Murphy B, Redman JR. The effects of cannabis and alcohol on simulated arterial driving: Influences of driving experience and task demand. Accid Anal Prev. 2010 May;42(3):859-66. doi: 10.1016/j.aap.2009.04.021.
PubMed 20380913
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Residual Effects of Alcohol on Young Drivers' Performance of Driving Related Skills
- ClinicalTrials.gov ID
- NCT02710578
- Acronym / sponsor ID
- 114/2014
- Conditions
- Psychomotor Impairment
- Keywords
- Alcohol impaired driving, Driving simulation, Residual effects of alcohol, Acute psychomotor effects of alcohol, Young drivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Ontario Ministry of Transportation
- Study start
- Mar 2016
- Primary completion
- 18 Jul 2017 (actual)
- Study completion
- 18 Jul 2017 (actual)
- First posted
- 17 Mar 2016 (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.
Given the known driving behavior of Driving Under the Influence of Alcohol and some of its parallel to driving under the influence of cannabis, this supplemental study aims to validate the sensitivity of the primary and secondary outcome measures employed in a cannabis and driving study currently in progress.
Detailed description
This study will examine the effects of an intoxicating dose of alcohol on driving-related skills among young drivers using driving simulator technology.
This study is a double-blind, placebo-controlled mixed design study, including randomized between-subjects comparison of the effects of alcohol intoxication and both between- and within-subjects examination of acute and residual effects at approximately 24 and 48 hours following one-time alcohol administration.
Initial contact with potential participants will be made by telephone, where study personnel will conduct a telephone screen for eligibility. Those telephone screened as eligible will attend CAMH for an eligibility assessment. Enrolled participants will complete four sessions on consecutive days: a practice day, an alcohol administration day, and a 24-hour and 48-hour post-alcohol session.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol | Active comparator | Drug: AlcoholAlcohol |
| Placebo | Placebo comparator | Drug: PlaceboTonic water |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females aged 19 to 25.
- Reported consumption of at least 1 heavy drinking episode (according to NIAAA criteria of 5 drinks for males and 4 for females within an occasion) in the 6 months prior to eligibility assessment.
- Held a valid class G or G2 Ontario driver's license (or equivalent from another jurisdiction) for at least 12 months.
- Willing to abstain from alcohol use for the duration of the study, and for 48 hours prior to Session 2.
- Provides written and informed consent.
Key exclusion criteria (7 listed)
- Taking medications or have any medical condition for which alcohol is contraindicated
- Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants).
- Diagnosis of severe medical or psychiatric conditions.
- Meets criteria for current or lifetime Substance Use Disorders (DSM-IV) with the exception of nicotine.
- Meets criteria for Alcohol Dependence (DSM-IV)
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 |
|---|---|---|
| AlcoholAlso: Smirnoff VodkaA single oral administration of an alcoholic beverage mixed in a 1:3 ratio of alcohol (Vodka) to tonic water to obtain a target BAC of 0.08mg% | Drug | Alcohol |
| PlaceboAlso: Tonic waterA single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage. | Drug | Placebo |
Primary outcome
Psychomotor impairment (driving)
Time frame: Approximate Time Frame: 30 minutes before, 30 minutes after, 24 and 48 hours after drinking
The driving simulator will objectively measure changes in driving behaviour after drinking alcohol.
3 secondary outcomes
Subjective alcohol effects
Time frame: Approximate Time Frame: 30 minutes before drinking, 5, 15, 30 minutes and 1, 2, 3, 24 and 48 hours post-drinking
Cognitive testing
Time frame: Approximate Time Frame: 30 minutes before drinking, and 1, 24 and 48 hours post-drinking
Breath alcohol content (BAC)
Time frame: Approximate Time Frame: 30 minutes before drinking, 5, 15, 30, minutes and 1, 2, 3, 24, and 48 hours post-drinking
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 29 Jan 2019.
- Background: PubMed 20380913Lenne MG, Dietze PM, Triggs TJ, Walmsley S, Murphy B, Redman JR. The effects of cannabis and alcohol on simulated arterial driving: Influences of driving experience and task demand. Accid Anal Prev. 2010 May;42(3):859-66. doi: 10.1016/j.aap.2009.04.021.
- The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.Link provided by the sponsor.
- 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.
Robert Mann, PhD principal investigator
Centre for Addiction and Mental Health
Bernard Le Foll, MD, PhD principal investigator
Centre for Addiction and Mental Health
Bruna Brands, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol in people with Psychomotor Impairment, run by Centre for Addiction and Mental Health 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 5 inclusion and 7 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 29 Jan 2019. 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?
Psychomotor impairment (driving) (time frame: Approximate Time Frame: 30 minutes before, 30 minutes after, 24 and 48 hours after drinking). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02710578, which also lists 1 linked publication.
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 29 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.