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Dose-response of Cannabis and Driving

Primary Purpose

Driving Impaired, Cognitive Impairment, Abuse Cannabis

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Cannabis

Placebo

About this trial

This is an interventional basic science trial for Driving Impaired

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Center for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

low dose

middle dose

high dose

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Mean speed

Speed of driving the simulator

Secondary Outcome Measures

Standard deviation of lateral position

Driving measures

reaction time

Driving measures

Blood concentrations of THC and metabolites

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

Oral fluid concentrations of THC and metabolites

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

Systolic and Diastolic Blood pressure

Vital signs

Heart rate

Vital signs

Respirations

Vital signs

Temperature

Vital signs

Visual Analog Scales

Tests designed to assess the degree of subjective effects of the drug. The questions will be scored on a scale from 0 to 100 and will consist of: 'I like this drug effect', 'this feels like cannabis', 'I feel this effect', 'I feel this high', 'I feel the good effects', 'I feel the bad effects', 'I feel the rush'

Verbal free recall test

Test of memory: Participants will be asked to recall words that are read from a list

Useful field of view

A computer test for visual processing speed, selective and divided attention

Full Information

NCT ID

NCT03656029

First Posted

August 8, 2018

Last Updated

October 5, 2022

Sponsor

Centre for Addiction and Mental Health

1. Study Identification

Unique Protocol Identification Number

NCT03656029

Brief Title

Dose-response of Cannabis and Driving

Official Title

Dose-dependent Effects of Smoked Cannabis on Simulated Driving Performance

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

June 4, 2021 (Actual)

Primary Completion Date

June 14, 2022 (Actual)

Study Completion Date

June 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Driving Impaired, Cognitive Impairment, Abuse Cannabis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

low dose

Arm Type

Active Comparator

Arm Description

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

Arm Title

middle dose

Arm Type

Active Comparator

Arm Description

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

Arm Title

high dose

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cannabis

Intervention Description

Participants will smoke as much of the cigarette as they wish

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will smoke a placebo cigarette

Primary Outcome Measure Information:

Title

Mean speed

Description

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 Outcome Measure Information:

Title

Standard deviation of lateral position

Description

Driving measures

Time Frame

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

Title

reaction time

Description

Driving measures

Time Frame

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

Title

Blood concentrations of THC and metabolites

Description

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

Title

Oral fluid concentrations of THC and metabolites

Description

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

Title

Systolic and Diastolic Blood pressure

Description

Vital signs

Time Frame