Psychomotor ImpairmentNCT03106363
Combined Alcohol and Cannabis Effects on Skills of Young Drivers
A study testing alcohol and delta 9 tetrahydrocannabinol in people with Psychomotor Impairment, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Alcohol and cannabis are the two most widely used substances of abuse in the world and are the psychoactive substances most often found in seriously and fatally injured drivers. In a recent study, it was observed that individuals who reported both driving under the influence of alcohol (DUIA) and the influence of… Read more about this study
- Who is it for?
- Ages 19 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychomotor Impairment
- What is being tested?
- alcohol and delta 9 tetrahydrocannabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2017to 17 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Use of cannabis at least once a week confirmed by urine point-of-care testing;
- Males who report consuming at least 5 drinks and females who report consuming at least 4 drinks in about 2 hours in the past 6 months and at least one episode of rapid alcohol consumption in the past 6 months (3 or more drinks over a span of one hour)
- 19-29 years of age;
- Holds a class G or G2 Ontario driver's licence (or equivalent from another jurisdiction) for at least 12 months;
- Willing to abstain from using alcohol for 48 hours and cannabis for 72 hours prior to Practice and Test Sessions.
- Willing to abstain from all other drugs not prescribed for medical purposes for the duration of the study;
- Provides written and informed consent.
Who cannot join
- Urine toxicology screens negative for cannabis upon eligibility assessment;
- Diagnosis of severe medical or psychiatric conditions;
- Females: Pregnancy or breastfeeding;
- Meets criteria for Alcohol or Substance Dependence (current or lifetime) (DSM-IV);
- Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants);
- Taking medications or have any medical condition for which alcohol is contraindicated;
- First-degree relative diagnosed with schizophrenia;
- Severe allergy to citrus (lemon-lime).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combined Alcohol and Cannabis on Young Drivers' Simulated Driving
Alcohol and cannabis are the two most widely used substances of abuse in the world and are the psychoactive substances most often found in seriously and fatally injured drivers. In a recent study, it was observed that individuals who reported both driving under the influence of alcohol (DUIA) and the influence of cannabis (DUIC) experienced collision risk that was nearly 4 times that of individuals who reported driving after using only one of these drugs. Recent research in the United States and Canada indicates that the prevalence of DUIC among young drivers of high school and university age, and young adults is similar to, or higher than, the prevalence of DUIA. This is a serious public health issue, since motor vehicle collisions are the leading cause of death in this age group. Given the frequency with which alcohol and cannabis are consumed together, it is important to understand their combined effects on driver behaviour. The current study will examine the acute effects of a moderate dose of cannabis (12.5% THC) combined with an intoxicating amount of alcohol (BAC=0.08) on driving simulator performance of young drivers. Following an eligibility screening and practice session, a total of 70 participants aged 19 to 29 years will each complete 4 experimental sessions. During each session, participants will drink alcohol or placebo alcohol and smoke an active or placebo cannabis cigarette. The effects of alcohol and cannabis on the performance of driving-related skills will be assessed using a high-fidelity driving simulator. Cognitive, psychomotor, and mood effects will also be assessed.
Read the detailed description
The proposed study will pursue the following primary aims:
Aim 1: Examine the acute effects of a moderate dose of cannabis (12.5% THC) combined with an intoxicating amount of alcohol (BAC=0.08) on driving simulator performance of young drivers. Simulated driving performance, tests of cognition, verbal memory, and mood will be measured concurrently with BAC and levels of cannabinoids in biological fluids before and after acute drug exposure in male and female drivers aged 19 to 29. BAC and biological fluids will be measured up to 5 hours following drug exposure.
Aim 2: Explore the effects of driving history, driving attitudes, and individual difference measures (e.g., demographics, drug and alcohol use, etc.) on the acute effects of alcohol and cannabis on driving simulator performance of young drivers. Exploratory analyses will be undertaken to determine if the acute effects of cannabis plus alcohol on the driving simulator task are influenced by these measures.
Study Design and Duration
This study will be a within-subjects, double-blind, double-dummy, placebo-controlled, counterbalanced, randomized clinical trial assessing the impact of alcohol and cannabis combined on driver behaviour. Although a placebo condition is part of the study, this is not a treatment study.
Initial contact with potential participants will be made via telephone, and study personnel will conduct a telephone screen for eligibility. Upon eligibility confirmation by telephone, participants will be asked to attend CAMH for an eligibility assessment. Participants will attend CAMH for a total of 6 study sessions (an eligibility assessment, a practice day, and 4 test sessions).
At each of four test sessions, participants will undergo one of these alcohol and cannabis exposure conditions: 1) placebo alcohol and placebo cannabis; 2) intoxicating dose of alcohol and placebo cannabis; 3) placebo alcohol and active cannabis, and; 4) intoxicating dose of alcohol and active cannabis. The order of these conditions will be randomly assigned. Participants will complete the alcohol manipulation followed by the cannabis manipulation. The alcohol and cannabis exposure sessions will be separated by at least 72 hours.
Participants will be asked not to use cannabis for 72 hours and alcohol for 48 hours prior to attending CAMH.
In certain instances, the Qualified Investigator may ask a participant to return for re-screening, e.g. repeat of urine test or other assessments performed for eligibility assessment. Also, in case of unforeseen delays in scheduling study participation, the Qualified Investigator will determine if there is a need to ask a participant to repeat some assessments, e.g., physical examination.
- Conditions
- Psychomotor Impairment
- Being tested
- alcohol, placebo alcohol, delta 9 tetrahydrocannabinol, placebo delta 9 tetrahydrocannabinol
- 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 ethanol
A single oral administration of an alcoholic beverage mixed in a 1:3 ratio of alcohol to tonic water to obtain a target blood alcohol content of 0.08mg%.
placebo alcoholDrug
Also called tonic water
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
delta 9 tetrahydrocannabinolDrug
Also called marijuana, cannabis sativa
A single cannabis cigarette (potency 12.5% delta 9 tetrahydrocannabinol) will be given to participants to smoke over a 10 minute period, ad libitum. If the cannabis cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose.
placebo delta 9 tetrahydrocannabinolDrug
A single placebo cannabis cigarette (<0.03% delta 9 tetrahydrocannabinol) will be given to participants to smoke over a 10 minute period, ad libitum. If the placebo cannabis cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose.
| Study group | Role | What they receive |
|---|---|---|
| Active alcohol/active cannabis | Active comparator | Participant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette. Receives: Drug: alcohol; Drug: delta 9 tetrahydrocannabinol |
| Placebo alcohol/active cannabis | Active comparator | Participant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette. Receives: Drug: placebo alcohol; Drug: delta 9 tetrahydrocannabinol |
| Active alcohol/placebo cannabis | Active comparator | Participant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a placebo delta 9 tetrahydrocannabinol (< 0.03%) cigarette. Receives: Drug: alcohol; Drug: placebo delta 9 tetrahydrocannabinol |
| Placebo alcohol/placebo cannabis | Placebo comparator | Participant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a placebo delta 9 tetrahydrocannabinol (< 0.03%) cigarette. Receives: Drug: placebo alcohol; Drug: placebo delta 9 tetrahydrocannabinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor Impairment: Standard Deviation of Lateral Position
The driving simulator objectively measures changes in driving behavior after alcohol and/or cannabis exposure. Standard deviation of lateral position (SDLP) is a measure of lane control (higher SDLP indicates worse lane control).
Measured: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.
Secondary outcomes (4)
Psychomotor Impairment: Mean Speed
The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure. Mean speed during the driving scenarios is measured by the simulator.
Measured: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.
Psychomotor Impairment: Standard Deviation of Speed
The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure. The simulator also (in addition to mean speed) measures standard deviation of speed.
Measured: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.
Psychomotor Impairment: Maximum Speed
The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure. The simulator measures maximum speed over the duration of the scenarios.
Measured: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.]
Psychomotor Impairment: Brake Latency
The driving simulator objectively measures changes in driving behavior after alcohol and/or cannabis exposure. During specific reaction time scenarios, participants must stop as quickly as possible after certain visual cues. The brake latency variable is measured as the mean stop/reaction time in seconds after the visual cue is presented.
Measured: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur at baseline and approximately 45 minutes after Time 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start4 Jul 2017
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a within-subjects, counterbalanced, placebo-controlled study. Four sessions are completed by participants: 1) alcohol and cannabis (placebo alcohol and placebo cannabis; 2) placebo alcohol and active cannabis; 3) alcohol and placebo cannabis; 4) alcohol and active cannabis). Session order is randomized. Participants and Investigator are blinded.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Health Canada
- Responsible party
- Principal investigator, Christine Wickens, Centre for Addiction and Mental Health
- Investigators
- Christine M Wickens, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106363
- Sponsor's protocol ID
- 123-2015
- Status last verified
- Mar 2024
- First submitted
- 4 Apr 2017
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 20380913Downey LA, King R, Papafotiou K, Swann P, Ogden E, Boorman M, Stough C. The effects of cannabis and alcohol on simulated driving: Influences of dose and experience. Accid Anal Prev. 2013 Jan;50:879-86. doi: 10.1016/j.aap.2012.07.016. Epub 2012 Aug 4.
PubMed 22871272Di Ciano P, Brands B, Fares A, Wright M, Stoduto G, Byrne P, McGrath M, Hasan OSM, Le Foll B, Wickens CM. The Utility of THC Cutoff Levels in Blood and Saliva for Detection of Impaired Driving. Cannabis Cannabinoid Res. 2023 Jun;8(3):408-413. doi: 10.1089/can.2022.0187. Epub 2023 Feb 2.
PubMed 36730769
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Alcohol and Cannabis on Young Drivers' Simulated Driving
- ClinicalTrials.gov ID
- NCT03106363
- Acronym / sponsor ID
- 123-2015
- Conditions
- Psychomotor Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Health Canada
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Posted 24 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alcohol and cannabis are the two most widely used substances of abuse in the world and are the psychoactive substances most often found in seriously and fatally injured drivers. In a recent study, it was observed that individuals who reported both driving under the influence of alcohol (DUIA) and the influence of cannabis (DUIC) experienced collision risk that was nearly 4 times that of individuals who reported driving after using only one of these drugs. Recent research in the United States and Canada indicates that the prevalence of DUIC among young drivers of high school and university age, and young adults is similar to, or higher than, the prevalence of DUIA. This is a serious public health issue, since motor vehicle collisions are the leading cause of death in this age group. Given the frequency with which alcohol and cannabis are consumed together, it is important to understand their combined effects on driver behaviour. The current study will examine the acute effects of a moderate dose of cannabis (12.5% THC) combined with an intoxicating amount of alcohol (BAC=0.08) on driving simulator performance of young drivers. Following an eligibility screening and practice session, a total of 70 participants aged 19 to 29 years will each complete 4 experimental sessions. During each session, participants will drink alcohol or placebo alcohol and smoke an active or placebo cannabis cigarette. The effects of alcohol and cannabis on the performance of driving-related skills will be assessed using a high-fidelity driving simulator. Cognitive, psychomotor, and mood effects will also be assessed.
Detailed description
The proposed study will pursue the following primary aims:
Aim 1: Examine the acute effects of a moderate dose of cannabis (12.5% THC) combined with an intoxicating amount of alcohol (BAC=0.08) on driving simulator performance of young drivers. Simulated driving performance, tests of cognition, verbal memory, and mood will be measured concurrently with BAC and levels of cannabinoids in biological fluids before and after acute drug exposure in male and female drivers aged 19 to 29. BAC and biological fluids will be measured up to 5 hours following drug exposure.
Aim 2: Explore the effects of driving history, driving attitudes, and individual difference measures (e.g., demographics, drug and alcohol use, etc.) on the acute effects of alcohol and cannabis on driving simulator performance of young drivers. Exploratory analyses will be undertaken to determine if the acute effects of cannabis plus alcohol on the driving simulator task are influenced by these measures.
Study Design and Duration
This study will be a within-subjects, double-blind, double-dummy, placebo-controlled, counterbalanced, randomized clinical trial assessing the impact of alcohol and cannabis combined on driver behaviour. Although a placebo condition is part of the study, this is not a treatment study.
Initial contact with potential participants will be made via telephone, and study personnel will conduct a telephone screen for eligibility. Upon eligibility confirmation by telephone, participants will be asked to attend CAMH for an eligibility assessment. Participants will attend CAMH for a total of 6 study sessions (an eligibility assessment, a practice day, and 4 test sessions).
At each of four test sessions, participants will undergo one of these alcohol and cannabis exposure conditions: 1) placebo alcohol and placebo cannabis; 2) intoxicating dose of alcohol and placebo cannabis; 3) placebo alcohol and active cannabis, and; 4) intoxicating dose of alcohol and active cannabis. The order of these conditions will be randomly assigned. Participants will complete the alcohol manipulation followed by the cannabis manipulation. The alcohol and cannabis exposure sessions will be separated by at least 72 hours.
Participants will be asked not to use cannabis for 72 hours and alcohol for 48 hours prior to attending CAMH.
In certain instances, the Qualified Investigator may ask a participant to return for re-screening, e.g. repeat of urine test or other assessments performed for eligibility assessment. Also, in case of unforeseen delays in scheduling study participation, the Qualified Investigator will determine if there is a need to ask a participant to repeat some assessments, e.g., physical examination.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a within-subjects, counterbalanced, placebo-controlled study. Four sessions are completed by participants: 1) alcohol and cannabis (placebo alcohol and placebo cannabis; 2) placebo alcohol and active cannabis; 3) alcohol and placebo cannabis; 4) alcohol and active cannabis). Session order is randomized. Participants and Investigator are blinded.
| Arm | Type | Receives |
|---|---|---|
| Active alcohol/active cannabis | Active comparator | Drug: alcohol, Drug: delta 9 tetrahydrocannabinolParticipant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette. |
| Placebo alcohol/active cannabis | Active comparator | Drug: placebo alcohol, Drug: delta 9 tetrahydrocannabinolParticipant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette. |
| Active alcohol/placebo cannabis | Active comparator | Drug: alcohol, Drug: placebo delta 9 tetrahydrocannabinolParticipant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a placebo delta 9 tetrahydrocannabinol (< 0.03%) cigarette. |
| Placebo alcohol/placebo cannabis | Placebo comparator | Drug: placebo alcohol, Drug: placebo delta 9 tetrahydrocannabinolParticipant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a placebo delta 9 tetrahydrocannabinol (< 0.03%) cigarette. |
Who may qualify
- Ages
- 19 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Use of cannabis at least once a week confirmed by urine point-of-care testing;
- Males who report consuming at least 5 drinks and females who report consuming at least 4 drinks in about 2 hours in the past 6 months and at least one episode of rapid alcohol consumption in the past 6 months (3 or more drinks over a span of one hour)
- 19-29 years of age;
- Holds a class G or G2 Ontario driver's licence (or equivalent from another jurisdiction) for at least 12 months;
- Willing to abstain from using alcohol for 48 hours and cannabis for 72 hours prior to Practice and Test Sessions.
Key exclusion criteria (8 listed)
- Urine toxicology screens negative for cannabis upon eligibility assessment;
- Diagnosis of severe medical or psychiatric conditions;
- Females: Pregnancy or breastfeeding;
- Meets criteria for Alcohol or Substance Dependence (current or lifetime) (DSM-IV);
- Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants);
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: ethanolA single oral administration of an alcoholic beverage mixed in a 1:3 ratio of alcohol to tonic water to obtain a target blood alcohol content of 0.08mg%. | Drug | Active alcohol/active cannabis, Active alcohol/placebo cannabis |
| placebo alcoholAlso: tonic waterA single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage. | Drug | Placebo alcohol/active cannabis, Placebo alcohol/placebo cannabis |
| delta 9 tetrahydrocannabinolAlso: marijuana, cannabis sativaA single cannabis cigarette (potency 12.5% delta 9 tetrahydrocannabinol) will be given to participants to smoke over a 10 minute period, ad libitum. If the cannabis cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose. | Drug | Active alcohol/active cannabis, Placebo alcohol/active cannabis |
| placebo delta 9 tetrahydrocannabinolA single placebo cannabis cigarette (<0.03% delta 9 tetrahydrocannabinol) will be given to participants to smoke over a 10 minute period, ad libitum. If the placebo cannabis cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose. | Drug | Active alcohol/placebo cannabis, Placebo alcohol/placebo cannabis |
Primary outcome
Psychomotor Impairment: Standard Deviation of Lateral Position
Time frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.
The driving simulator objectively measures changes in driving behavior after alcohol and/or cannabis exposure. Standard deviation of lateral position (SDLP) is a measure of lane control (higher SDLP indicates worse lane control).
4 secondary outcomes
Psychomotor Impairment: Mean Speed
Time frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.
Psychomotor Impairment: Standard Deviation of Speed
Time frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.
Psychomotor Impairment: Maximum Speed
Time frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.]
Psychomotor Impairment: Brake Latency
Time frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur at baseline and approximately 45 minutes after Time 0.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Background: PubMed 22871272Downey LA, King R, Papafotiou K, Swann P, Ogden E, Boorman M, Stough C. The effects of cannabis and alcohol on simulated driving: Influences of dose and experience. Accid Anal Prev. 2013 Jan;50:879-86. doi: 10.1016/j.aap.2012.07.016. Epub 2012 Aug 4.
- Derived from this study: PubMed 36730769Di Ciano P, Brands B, Fares A, Wright M, Stoduto G, Byrne P, McGrath M, Hasan OSM, Le Foll B, Wickens CM. The Utility of THC Cutoff Levels in Blood and Saliva for Detection of Impaired Driving. Cannabis Cannabinoid Res. 2023 Jun;8(3):408-413. doi: 10.1089/can.2022.0187. Epub 2023 Feb 2.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreLink 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.
Christine M Wickens, 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 and delta 9 tetrahydrocannabinol 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 7 inclusion and 8 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 24 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 24 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Standard Deviation of Lateral Position (time frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.). 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 NCT03106363, which also lists 3 linked publications.
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 24 Jul 2026.