Dose-response of Cannabis and Driving

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-04

Study Completion Date

2022-06-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Driving Impaired Cognitive Impairment Abuse Cannabis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This will be a within-subjects, counterbalanced, placebo-controlled study of placebo or 3 doses of cannabis

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Participants will smoke a single smoked placebo (\<0.1% THC) cannabis cigarette

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will smoke a placebo cigarette

low dose

Participants will smoke a single low dose (6.25% THC) of smoked cannabis cigarette

Group Type ACTIVE_COMPARATOR

Cannabis

Intervention Type DRUG

Participants will smoke as much of the cigarette as they wish

middle dose

Participants will smoke a single intermediate dose (12.5% THC) of smoked cannabis cigarette

Group Type ACTIVE_COMPARATOR

Cannabis

Intervention Type DRUG

Participants will smoke as much of the cigarette as they wish

high dose

Participants will smoke a single high dose (22% THC) of smoked cannabis cigarette

Group Type ACTIVE_COMPARATOR

Cannabis

Intervention Type DRUG

Participants will smoke as much of the cigarette as they wish

Interventions

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Cannabis

Participants will smoke as much of the cigarette as they wish

Intervention Type DRUG

Placebo

Participants will smoke a placebo cigarette

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes