INTERVENTIONALCOMPLETEDNCT03656029

Dose-dependent Effects of Smoked Cannabis on Simulated Driving Performance

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2022-10-07

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 36 (ACTUAL)
Start date: 2021-06-04
Sponsor: Centre for Addiction and Mental Health
Design: RANDOMIZED · CROSSOVER · BASIC SCIENCE
Locations: 1
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

Cannabis

Participants will smoke as much of the cigarette as they wish

DRUG

Placebo

Participants will smoke a placebo cigarette

Eligibility

Population and criteria

Sex: ALL
Minimum age: 19 Years
Maximum age: 45 Years
Healthy volunteers: Accepted

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

primary outcomes

primary measures

Mean speed

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

Speed of driving the simulator

secondary outcomes

secondary measures

Standard deviation of lateral position

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

Driving measures

reaction time

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

Driving measures

Blood concentrations of THC and metabolites

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

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

Oral fluid concentrations of THC and metabolites

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

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