Combined Alcohol and Cannabis Effects on Skills of Young Drivers
Effects of Combined Alcohol and Cannabis on Young Drivers' Simulated Driving
1 other identifier
interventional
85
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jul 2017
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 10, 2017
CompletedStudy Start
First participant enrolled
July 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2020
CompletedFebruary 10, 2020
February 1, 2020
2.5 years
April 4, 2017
February 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Psychomotor impairment: Standard deviation of lateral position
The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure.
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 (12)
Psychomotor impairment: Mean speed, standard deviation of speed, and maximum speed
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: Minimum time to collision and brake latency
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: Number of collisions
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.
Subjective alcohol and cannabis effects
Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Visual analogue scales are administered within 2 hours before as well as approximately 15, 30, 45, and 75 minutes and 2, 3, 4, and 5 hours after Time 0.
Cognitive testing
Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Cognitive testing is administered within 2 hours before Time 0 as well as approximately 75 minutes after Time 0.
- +7 more secondary outcomes
Study Arms (4)
Alcohol/Placebo Cannabis
ACTIVE COMPARATORParticipant 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/Cannabis
ACTIVE COMPARATORParticipant 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.
Alcohol/Cannabis
ACTIVE COMPARATORParticipant 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/Placebo Cannabis
PLACEBO COMPARATORParticipant 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.
Interventions
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.
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 (as this is a double-blind study).
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%.
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
Eligibility Criteria
You may qualify if:
- 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)
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre for Addiction and Mental Healthlead
- Canadian Institutes of Health Research (CIHR)collaborator
- Health Canadacollaborator
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 2S1, Canada
Related Publications (3)
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.
PMID: 20380913BACKGROUNDDowney 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.
PMID: 22871272BACKGROUNDDi 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.
PMID: 36730769DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine M Wickens, PhD
Centre for Addiction and Mental Health
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Independent Scientist, Institute for Mental Health Policy Research
Study Record Dates
First Submitted
April 4, 2017
First Posted
April 10, 2017
Study Start
July 4, 2017
Primary Completion
January 17, 2020
Study Completion
January 17, 2020
Last Updated
February 10, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share