Dose-response of Cannabis and Driving

Centre for Addiction and Mental Health36 enrolled

Overview

Epidemiological studies have established a link between collisions while driving and cannabis use. With the changing legal landscape around cannabis, there is much interest in determining per se limits of cannabis while driving. The present study will evaluate driving on a driving simulator after smoking placebo or cannabis with 3 different levels of THC. THC is the active component in cannabis and blood, urine and oral fluid levels of THC will be correlated with driving impairment.

Participants will attend the laboratory for 4 separate sessions, separated by about a week. In each session, participants will receive one of 3 doses of smoked cannabis or a placebo. Participants will not know which dose they are receiving. Participants will complete questionnaires, do cognitive tests and drive on a driving simulator before and after smoking the cannabis or placebo cigarette. Blood, urine and oral fluid will be collected throughout the 7-8 hour session to determine levels of THC and its metabolites. These values will be correlated with measures of driving impairment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Driving Impaired Cognitive Impairment Abuse Cannabis

Interventions

CannabisDRUG

Participants will smoke as much of the cigarette as they wish

PlaceboDRUG

Participants will smoke a placebo cigarette

Eligibility

Sex: ALLMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Near daily use of cannabis (1-5 days/week) confirmed by self-report and urine screening * Has held a class G2 or G licence (or equivalent from another jurisdiction) for at least 12 months * Willing to abstain from using cannabis for 72 hours prior to each practice or test session * Willing to abstain from alcohol for 48 hours prior to each session, and to abstain from all other drugs not medically required for the duration of the study (beginning 48 hours prior to the practice session) * Provides written and informed consent Exclusion Criteria: * Diagnosis of severe medical or psychiatric condition * Meets criteria for current or lifetime alcohol or other substance use disorder, except tobacco use disorder and caffeine use disorder * Regular user of medication that may affect cognitive functioning and/or driver performance * Family history of schizophrenia or other psychotic disorder * Pregnant, looking to become pregnant, or breastfeeding

Locations (1)

Center for Addiction and Mental Health

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Mean speed

Speed of driving the simulator

Time frame: Change in speed of driving between the time before smoking the cigarette and either 30 or 90 minutes after smoking the cigarette

Secondary Outcomes

Standard deviation of lateral position

Driving measures

Time frame: Change in measure from before smoking the cigarette to either 30 or 90 minutes after smoking

reaction time

Driving measures

Time frame: Change in measure from before smoking the cigarette to either 30 or 90 minutes after smoking

Blood concentrations of THC and metabolites

Blood will be taken to determine how much THC entered the blood

Time frame: Change from before smoking cigarette to various time points after smoking: 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 2hours, 3 hours, 4 hours, 5 hours and 6 hours

Oral fluid concentrations of THC and metabolites

Participants will provide oral fluid to determine how much THC is in the oral fluid

Time frame: Change from levels before smoking to 4 time points after smoking: 30 minutes, 90 minutes, 2 hours and 6 hours

Systolic and Diastolic Blood pressure

Vital signs

Time frame: Change from before smoking to a number of time points after smoking: 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 2hours, 3 hours, 4 hours, 5 hours and 6 hours

Heart rate

Vital signs

Time frame: Change from before smoking to a number of time points after smoking: 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 2hours, 3 hours, 4 hours, 5 hours and 6 hours

Data from ClinicalTrials.gov

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