Cannabis Effects on Driving-related Skills of Young Drivers

NCT01592409 | Completed Results

• 1 other identifier: 125/2011
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Psychomotor Impairment

Keywords

cannabis impaired driving; driving simulation; acute psychopharmacologic effects of cannabis; residual effects of cannabis; young drivers

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximate: at baseline (30 minutes before smoking), 30 minutes after smoking

Study Arms (2)

Active cannabis

ACTIVE COMPARATOR

In this condition, participants will receive a cigarette containing 12.5% active THC.

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).

Drug: Placebo

Interventions

delta-9-tetrahydrocannabinol DRUG

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.

Also known as: cannabis sativa, marijuana

Active cannabis

Placebo DRUG

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).

Also known as: cannabis sativa, marijuana

Placebo

Eligibility Criteria

• Age: 19 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Health Canada: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (23)

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  BACKGROUND

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  BACKGROUND

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  PMID: 17960301 BACKGROUND

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  BACKGROUND

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  PMID: 7648994 BACKGROUND

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  PMID: 18494838 BACKGROUND

Related Links

• 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

MeSH Terms

Conditions

Psychomotor Disorders

Interventions

Dronabinol; nabiximols

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Limitations and Caveats

The study examined simulated driving behavior of young regular cannabis users (1 to 4 times per week) and the generalization to new or frequent cannabis users, older drivers, and to real-world driving is unclear.

Results Point of Contact

• Title: Dr. Robert Mann, Senior Scientist
• Organization: Centre for Addiction and Mental Health

robert.mann@camh.ca

416-535-8501

Study Officials

• Robert Mann, Ph.D.

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

• Bernard Le Foll, M.D., Ph.D.

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 11, 2019
• Results First Posted: February 11, 2019

Record last verified: 2018-09

Locations

CA (1)