Cannabis Effects on Driving-related Skills of Young Drivers
NCT ID: NCT01592409
Last Updated: 2019-02-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
99 participants
INTERVENTIONAL
2012-07-31
2016-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dose-response of Cannabis and Driving
NCT03656029
Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users
NCT02061020
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I
NCT02709954
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition
NCT02404688
High Confusion: Cannabis & Driving
NCT06236815
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study Objectives
1. 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.
2. 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.
3. 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.
4. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active cannabis
In this condition, participants will receive a cigarette containing 12.5% active THC.
delta-9-tetrahydrocannabinol
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.
Placebo
In this condition, participants will receive a cannabis cigarette where the active THC has been removed (contains 0% THC).
Placebo
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
delta-9-tetrahydrocannabinol
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.
Placebo
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
Exclusion Criteria
* 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).
* Is pregnant, is trying to become pregnant, or is currently breastfeeding.
* 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.
19 Years
25 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Health Canada
OTHER_GOV
Centre for Addiction and Mental Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Robert Mann
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Mann, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Bernard Le Foll, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Brault 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.
Siliquini 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.
Stoduto 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.
Drummer 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.
Lacey 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.
Asbridge 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.
Adlaf EM, Mann RE, Paglia A. Drinking, cannabis use and driving among Ontario students. CMAJ. 2003 Mar 4;168(5):565-6.
Fischer 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.
McGuire F, Dawe M, Shield KD, Rehm J, Fishcher B. Driving under the influence of cannabis or alcohol in a cohort of high-frequency cannabis users: prevalence and reflections on current interventions. Canadian Journal of Criminology and Criminal Justice 53(2): 247-259, 2011
Pope HG Jr, Gruber AJ, Yurgelun-Todd D. The residual neuropsychological effects of cannabis: the current status of research. Drug Alcohol Depend. 1995 Apr;38(1):25-34. doi: 10.1016/0376-8716(95)01097-i.
Heishman SJ, Huestis MA, Henningfield JE, Cone EJ. Acute and residual effects of marijuana: profiles of plasma THC levels, physiological, subjective, and performance measures. Pharmacol Biochem Behav. 1990 Nov;37(3):561-5. doi: 10.1016/0091-3057(90)90028-g.
Smiley A. Marijuana: On-road and driving simulator studies. Alcohol, Drugs, and Driving. 2:121-34, 1986
Crancer A Jr, Dille JM, Delay JC, Wallace JE, Haykin MD. Comparison of the effects of marihuana and alcohol on simulated driving performance. Science. 1969 May 16;164(3881):851-4. doi: 10.1126/science.164.3881.851.
Cone EJ, Huestis MA. Relating blood concentrations of tetrahydrocannabinol and metabolites to pharmacologic effects and time of marijuana usage. Ther Drug Monit. 1993 Dec;15(6):527-32. doi: 10.1097/00007691-199312000-00013.
Harder S, Rietbrock S. Concentration-effect relationship of delta-9-tetrahydrocannabiol and prediction of psychotropic effects after smoking marijuana. Int J Clin Pharmacol Ther. 1997 Apr;35(4):155-9.
McLaren J, Swift W, Dillon P, Allsop S. Cannabis potency and contamination: a review of the literature. Addiction. 2008 Jul;103(7):1100-9. doi: 10.1111/j.1360-0443.2008.02230.x. Epub 2008 May 20.
Related Links
Access external resources that provide additional context or updates about the study.
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 Centre
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
125/2011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.