Psychomotor ImpairmentNCT01592409
Cannabis Effects on Driving-related Skills of Young Drivers
A study testing delta-9-tetrahydrocannabinol in people with Psychomotor Impairment, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Motor vehicle collisions are the leading cause of death for young people. The investigators have recently found that driving after using cannabis is more common among young Canadian drivers than driving after drinking. 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?
- delta-9-tetrahydrocannabinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Sep 2016
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females aged 19 to 25
- Regular cannabis users (between one and four times per week)
- 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 cannabis use for the duration of the study, and for 48 hours prior to Session 2.
- Provides written and informed consent
- Urine toxicology result positive for THC (indicating recent use of cannabis).
Who cannot join
- Positive breathalyzer results for alcohol on any given study day.
- Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants).
- Diagnosis of severe medical or psychiatric conditions.
- A first degree relative diagnosed with schizophrenia.
- Meets criteria for current or lifetime Substance Use Disorders (DSM-IV) with the exception of nicotine.
- Meets criteria for Cannabis Dependence (DSM-IV).
Show all 10Show fewer
- Is pregnant, is trying to become pregnant, or is currently breastfeeding.
- Ongoing Exclusion Criteria:
- Upon eligibility assessment, toxicology results indicate that the participant has not used cannabis recently.
- Any toxicology screen after Session 2 - Practice Day indicating a psychoactive substance has been used other than cannabis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute and Residual Effects of Cannabis on Young Drivers' Performance of Driving-related Skills
Motor vehicle collisions are the leading cause of death for young people. The investigators have recently found that driving after using cannabis is more common among young Canadian drivers than driving after drinking. While this observation raises concerns, the effects of cannabis on driving-related skills in this age group are not well understood. As well, evidence suggests that residual effects of cannabis on driving-related skills may be observed up to 24 hours later. These residual effects may have important implications for the effects of cannabis use on collision risk, but little evidence on them in available. This study will examine the effects of a single dose of cannabis (marijuana) on driving-related skills immediately following consumption, 24 hours later, and 48 hours later. To date, the residual effect at 48 hours has not been examined. A total of 142 subjects aged 19 to 25 years old will be randomly assigned to smoke either a placebo or active cannabis cigarette (12.5% THC potency). Following an eligibility screening and practice session, participants will attend 3 testing days; drug-administration, 24-hour follow-up and 48-hour follow-up. The effects of cannabis/placebo on performance of driving-related skills using a high-fidelity driving simulator will be assessed on each testing day. The effects of cannabis on mood, cognition, memory and complex reaction time will also be assessed. Identifying factors that affect the collision risks experienced by young drivers is a public health priority. While many young people believe that cannabis does not impair driving, some recent studies suggest that these may be very dangerous beliefs. This study will provide important information on how cannabis may affect the driving skills of young drivers, to inform efforts to understand and address cannabis-related collision in this age group.
Read the detailed description
This study will test the prediction that residual effects of an acute dose of cannabis on driving-related skills will be observed in a group of young drivers 48 hours following a single dose of smoked cannabis, and will also examine the effects of an acute dose of cannabis on those skills using driving simulator technology.
Study Objectives
- Examine the residual effects of a moderate dose of cannabis (12.5% THC) on driving simulator performance of young drivers. Simulated driving performance, tests of cognition, verbal memory, and mood will be measured concurrently with levels of cannabinoids in biological fluids at approximately 24 and 48 hours following acute drug exposure in male and female drivers aged 19 to 25. We will test the hypothesis that performance on a high-fidelity driving simulator task will be significantly impaired approximately 24 hours following a dose of cannabis in comparison to a placebo condition.
- Examine the acute effects of a moderate dose of cannabis (12.5% THC) on driving simulator performance of young drivers. Simulated driving performance, tests of cognition, verbal memory, and mood will be measured concurrently with levels of cannabinoids in biological fluids before and after drug administration. Cannabinoid levels in biological fluids will be measured over a 6 hour period following drug exposure. We will examine the relationship of cannabinoid levels to performance measures in this time frame.
- Explore the effects of driving history, driving attitudes, and individual difference measures (e.g., demographics, drug and alcohol use, etc.) on the acute and residual effects of cannabis on driving simulator performance of young drivers. Exploratory analyses will be undertaken to determine if the acute and residual effects of cannabis on the driving simulator task are influenced by these measures.
- Determine if a relationship exists between genetics and THC response. As an ancillary aim, blood samples may be collected for future research to determine if a relationship exists between genetic polymorphisms and pharmacokinetic and pharmacodynamic responses to cannabis.
Study Design and Duration
The study is a double-blind, placebo-controlled mixed-design study, including a randomized between-subjects comparison of the effects of smoked cannabis and both between- and within-subjects examination of its residual effects at 24 and 48 hours following one-time drug administration. Although a placebo condition is part of the study, this is not a treatment study.
Initial contact with potential subjects 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. The study will consist of 5 sessions for each subject (an eligibility assessment, a practice day, and three subsequent testing days). Participants will be asked not to use cannabis for 48 hours prior to attending the practice day (Session 2). Although Session 1 can be completed at any time prior to the remaining study sessions, Sessions 2 - 5 must be performed on consecutive days.
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
- delta-9-tetrahydrocannabinol, Placebo
- Keywords
- cannabis impaired driving, driving simulation, acute psychopharmacologic effects of cannabis, residual effects of cannabis, 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.
delta-9-tetrahydrocannabinolDrug
Also called cannabis sativa, marijuana
A single cannabis cigarette (potency 12.5% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose.
PlaceboDrug
Also called cannabis sativa, marijuana
A single placebo cannabis cigarette (0% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study).
| Study group | Role | What they receive |
|---|---|---|
| Active cannabis | Active comparator | In this condition, participants will receive a cigarette containing 12.5% active THC. Receives: Drug: delta-9-tetrahydrocannabinol |
| Placebo | Placebo comparator | In this condition, participants will receive a cannabis cigarette where the active THC has been removed (contains 0% THC). 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 driving behaviour during a number of pre-programmed driving scenarios. Zone/ Hazard performance measure: Mean Speed.
Measured: Approximate: at baseline (30 minutes before smoking), 30 minutes after smoking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2016
- Study completionSep 2016
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 (23)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
- 99 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, Robert Mann, Centre for Addiction and Mental Health
- Investigators
- Robert Mann, Ph.D., Principal investigator, Centre for Addiction and Mental HealthBernard Le Foll, M.D., Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592409
- Sponsor's protocol ID
- 125/2011
- Status last verified
- Sep 2018
- First submitted
- 3 May 2012
- Last updated
- 11 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Adlaf EM, Begin P, Sawka E. Canadian Addiction Survey (CAS): A national survey of Canadians' use of alcohol and other drugs: Prevalence of use and related harms: Detailed report. Ottawa, Canada: Canadian Cenre for Substance Abuse 2005
Johnston LD, O'Malley PM, Backman JG, Schulenber JE. Monitoring the future: National results on adolescent drug use. Bethesda, MD.: National Institute on Drug Abuse 2009
WHO - Programme on substance abuse. Cannabis: a health perspective and research agenda: World Health Organization 1997.
Chipman ML, Macdonald S, Mann RE. Being "at fault" in traffic crashes: does alcohol, cannabis, cocaine, or polydrug abuse make a difference? Inj Prev. 2003 Dec;9(4):343-8. doi: 10.1136/ip.9.4.343.
PubMed 14693897Brault M, Dussault C, Bouchard J, Lemire AM. The contribution of alcohol and other drugs among fatally injured drivers in Quebec: final results. Société de l'assurance automobile du Quebec 2002. Available from: http://www.saaq.gouv.qc.ca/publications/dossiers_etudes/drogue_an.pdf
Laumon B, Gadegbeku B, Martin JL, Biecheler MB; SAM Group. Cannabis intoxication and fatal road crashes in France: population based case-control study. BMJ. 2005 Dec 10;331(7529):1371. doi: 10.1136/bmj.38648.617986.1F. Epub 2005 Dec 1.
PubMed 16321993Siliquini R, Chiado Piat S, Gianino MM, Renga G. Drivers involved in road traffic accidents in Piedmont Region: psychoactive substances consumption. J Prev Med Hyg. 2007 Dec;48(4):123-8.
PubMed 18557306Stoduto G, Vingilis E, Kapur BM, Sheu WJ, McLellan BA, Liban CB. Alcohol and drug use among motor vehicle collision victims admitted to a regional trauma unit: demographic, injury, and crash characteristics. Accid Anal Prev. 1993 Aug;25(4):411-20. doi: 10.1016/0001-4575(93)90070-d.
PubMed 8357454Drummer OH, Gerostamoulos J, Batziris H, Chu M, Caplehorn J, Robertson MD, Swann P. The involvement of drugs in drivers of motor vehicles killed in Australian road traffic crashes. Accid Anal Prev. 2004 Mar;36(2):239-48. doi: 10.1016/s0001-4575(02)00153-7.
PubMed 14642878Lacey JH, Kelley-Baker T, Furr-Holden D, Voas RB, Romano E, Ramirez A, et al. 2007 National roadside survey of alcohol and drug use by drivers: Drug results. Washington, DC: National Highway Traffic Safety Administration 2009.
Blows S, Ivers RQ, Connor J, Ameratunga S, Woodward M, Norton R. Marijuana use and car crash injury. Addiction. 2005 May;100(5):605-11. doi: 10.1111/j.1360-0443.2005.01100.x.
PubMed 15847617Asbridge M, Poulin C, Donato A. Motor vehicle collision risk and driving under the influence of cannabis: evidence from adolescents in Atlantic Canada. Accid Anal Prev. 2005 Nov;37(6):1025-34. doi: 10.1016/j.aap.2005.05.006. Epub 2005 Jun 29.
PubMed 15992751Adlaf EM, Mann RE, Paglia A. Drinking, cannabis use and driving among Ontario students. CMAJ. 2003 Mar 4;168(5):565-6.
PubMed 12615749Fischer B, Rodopoulos J, Rehm J, Ivsins A. Toking and driving: Characteristics of Canadian university students who drive after cannabis use - an exploratory pilot study. Drugs Ed Prev Policy 13:179-87, 2006
O'Malley PM, Johnston LD. Drugs and driving by American high school seniors, 2001-2006. J Stud Alcohol Drugs. 2007 Nov;68(6):834-42. doi: 10.15288/jsad.2007.68.834.
PubMed 17960301
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Residual Effects of Cannabis on Young Drivers' Performance of Driving-related Skills
- ClinicalTrials.gov ID
- NCT01592409
- Acronym / sponsor ID
- 125/2011
- Conditions
- Psychomotor Impairment
- Keywords
- cannabis impaired driving, driving simulation, acute psychopharmacologic effects of cannabis, residual effects of cannabis, young drivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Health Canada
- Study start
- Jul 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Posted 11 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Motor vehicle collisions are the leading cause of death for young people. The investigators have recently found that driving after using cannabis is more common among young Canadian drivers than driving after drinking. While this observation raises concerns, the effects of cannabis on driving-related skills in this age group are not well understood. As well, evidence suggests that residual effects of cannabis on driving-related skills may be observed up to 24 hours later. These residual effects may have important implications for the effects of cannabis use on collision risk, but little evidence on them in available. This study will examine the effects of a single dose of cannabis (marijuana) on driving-related skills immediately following consumption, 24 hours later, and 48 hours later. To date, the residual effect at 48 hours has not been examined. A total of 142 subjects aged 19 to 25 years old will be randomly assigned to smoke either a placebo or active cannabis cigarette (12.5% THC potency). Following an eligibility screening and practice session, participants will attend 3 testing days; drug-administration, 24-hour follow-up and 48-hour follow-up. The effects of cannabis/placebo on performance of driving-related skills using a high-fidelity driving simulator will be assessed on each testing day. The effects of cannabis on mood, cognition, memory and complex reaction time will also be assessed. Identifying factors that affect the collision risks experienced by young drivers is a public health priority. While many young people believe that cannabis does not impair driving, some recent studies suggest that these may be very dangerous beliefs. This study will provide important information on how cannabis may affect the driving skills of young drivers, to inform efforts to understand and address cannabis-related collision in this age group.
Detailed description
This study will test the prediction that residual effects of an acute dose of cannabis on driving-related skills will be observed in a group of young drivers 48 hours following a single dose of smoked cannabis, and will also examine the effects of an acute dose of cannabis on those skills using driving simulator technology.
Study Objectives
- Examine the residual effects of a moderate dose of cannabis (12.5% THC) on driving simulator performance of young drivers. Simulated driving performance, tests of cognition, verbal memory, and mood will be measured concurrently with levels of cannabinoids in biological fluids at approximately 24 and 48 hours following acute drug exposure in male and female drivers aged 19 to 25. We will test the hypothesis that performance on a high-fidelity driving simulator task will be significantly impaired approximately 24 hours following a dose of cannabis in comparison to a placebo condition.
- Examine the acute effects of a moderate dose of cannabis (12.5% THC) on driving simulator performance of young drivers. Simulated driving performance, tests of cognition, verbal memory, and mood will be measured concurrently with levels of cannabinoids in biological fluids before and after drug administration. Cannabinoid levels in biological fluids will be measured over a 6 hour period following drug exposure. We will examine the relationship of cannabinoid levels to performance measures in this time frame.
- Explore the effects of driving history, driving attitudes, and individual difference measures (e.g., demographics, drug and alcohol use, etc.) on the acute and residual effects of cannabis on driving simulator performance of young drivers. Exploratory analyses will be undertaken to determine if the acute and residual effects of cannabis on the driving simulator task are influenced by these measures.
- Determine if a relationship exists between genetics and THC response. As an ancillary aim, blood samples may be collected for future research to determine if a relationship exists between genetic polymorphisms and pharmacokinetic and pharmacodynamic responses to cannabis.
Study Design and Duration
The study is a double-blind, placebo-controlled mixed-design study, including a randomized between-subjects comparison of the effects of smoked cannabis and both between- and within-subjects examination of its residual effects at 24 and 48 hours following one-time drug administration. Although a placebo condition is part of the study, this is not a treatment study.
Initial contact with potential subjects 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. The study will consist of 5 sessions for each subject (an eligibility assessment, a practice day, and three subsequent testing days). Participants will be asked not to use cannabis for 48 hours prior to attending the practice day (Session 2). Although Session 1 can be completed at any time prior to the remaining study sessions, Sessions 2 - 5 must be performed on consecutive days.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active cannabis | Active comparator | Drug: delta-9-tetrahydrocannabinolIn this condition, participants will receive a cigarette containing 12.5% active THC. |
| Placebo | Placebo comparator | Drug: PlaceboIn this condition, participants will receive a cannabis cigarette where the active THC has been removed (contains 0% THC). |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and females aged 19 to 25
- Regular cannabis users (between one and four times per week)
- 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 cannabis use for the duration of the study, and for 48 hours prior to Session 2.
- Provides written and informed consent
Key exclusion criteria (10 listed)
- Positive breathalyzer results for alcohol on any given study day.
- Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants).
- Diagnosis of severe medical or psychiatric conditions.
- A first degree relative diagnosed with schizophrenia.
- Meets criteria for current or lifetime Substance Use Disorders (DSM-IV) with the exception of nicotine.
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 |
|---|---|---|
| delta-9-tetrahydrocannabinolAlso: cannabis sativa, marijuanaA single cannabis cigarette (potency 12.5% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose. | Drug | Active cannabis |
| PlaceboAlso: cannabis sativa, marijuanaA single placebo cannabis cigarette (0% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study). | Drug | Placebo |
Primary outcome
Psychomotor Impairment (Driving)
Time frame: Approximate: at baseline (30 minutes before smoking), 30 minutes after smoking
The driving simulator will objectively measure driving behaviour during a number of pre-programmed driving scenarios. Zone/ Hazard performance measure: Mean Speed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAdlaf EM, Begin P, Sawka E. Canadian Addiction Survey (CAS): A national survey of Canadians' use of alcohol and other drugs: Prevalence of use and related harms: Detailed report. Ottawa, Canada: Canadian Cenre for Substance Abuse 2005
- BackgroundJohnston LD, O'Malley PM, Backman JG, Schulenber JE. Monitoring the future: National results on adolescent drug use. Bethesda, MD.: National Institute on Drug Abuse 2009
- BackgroundWHO - Programme on substance abuse. Cannabis: a health perspective and research agenda: World Health Organization 1997.
- Background: PubMed 14693897Chipman ML, Macdonald S, Mann RE. Being "at fault" in traffic crashes: does alcohol, cannabis, cocaine, or polydrug abuse make a difference? Inj Prev. 2003 Dec;9(4):343-8. doi: 10.1136/ip.9.4.343.
- BackgroundBrault M, Dussault C, Bouchard J, Lemire AM. The contribution of alcohol and other drugs among fatally injured drivers in Quebec: final results. Société de l'assurance automobile du Quebec 2002. Available from: http://www.saaq.gouv.qc.ca/publications/dossiers_etudes/drogue_an.pdf
- Background: PubMed 16321993Laumon B, Gadegbeku B, Martin JL, Biecheler MB; SAM Group. Cannabis intoxication and fatal road crashes in France: population based case-control study. BMJ. 2005 Dec 10;331(7529):1371. doi: 10.1136/bmj.38648.617986.1F. Epub 2005 Dec 1.
- Background: PubMed 18557306Siliquini R, Chiado Piat S, Gianino MM, Renga G. Drivers involved in road traffic accidents in Piedmont Region: psychoactive substances consumption. J Prev Med Hyg. 2007 Dec;48(4):123-8.
- Background: PubMed 8357454Stoduto G, Vingilis E, Kapur BM, Sheu WJ, McLellan BA, Liban CB. Alcohol and drug use among motor vehicle collision victims admitted to a regional trauma unit: demographic, injury, and crash characteristics. Accid Anal Prev. 1993 Aug;25(4):411-20. doi: 10.1016/0001-4575(93)90070-d.
- Background: PubMed 14642878Drummer OH, Gerostamoulos J, Batziris H, Chu M, Caplehorn J, Robertson MD, Swann P. The involvement of drugs in drivers of motor vehicles killed in Australian road traffic crashes. Accid Anal Prev. 2004 Mar;36(2):239-48. doi: 10.1016/s0001-4575(02)00153-7.
- BackgroundLacey JH, Kelley-Baker T, Furr-Holden D, Voas RB, Romano E, Ramirez A, et al. 2007 National roadside survey of alcohol and drug use by drivers: Drug results. Washington, DC: National Highway Traffic Safety Administration 2009.
- Background: PubMed 15847617Blows S, Ivers RQ, Connor J, Ameratunga S, Woodward M, Norton R. Marijuana use and car crash injury. Addiction. 2005 May;100(5):605-11. doi: 10.1111/j.1360-0443.2005.01100.x.
- Background: PubMed 15992751Asbridge M, Poulin C, Donato A. Motor vehicle collision risk and driving under the influence of cannabis: evidence from adolescents in Atlantic Canada. Accid Anal Prev. 2005 Nov;37(6):1025-34. doi: 10.1016/j.aap.2005.05.006. Epub 2005 Jun 29.
- 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.
Related trials for Psychomotor Impairment
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Deep Brain Stimulation + Therapy for Stroke
Stroke, Dysarthria
Not yet recruitingObservational study
Cognitive Function and Quality of Life in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment
RecruitingPhase 2
Inflammation and Depression in People With HIV
HIV, Depression
Active, not recruitingEarly Phase 1
Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
Alzheimer Disease, Anxiety
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, Ph.D. principal investigator
Centre for Addiction and Mental Health
Bernard Le Foll, M.D., Ph.D. 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 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 6 inclusion and 10 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 11 Feb 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?
Yes. Results are posted in the registry (first posted 11 Feb 2019). 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 (Driving) (time frame: Approximate: at baseline (30 minutes before smoking), 30 minutes after smoking). 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 NCT01592409, which also lists 23 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 11 Feb 2019.