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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03656029
Other study ID # 007-2018
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 4, 2021
Est. completion date June 14, 2022

Study information

Verified date October 2022
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 14, 2022
Est. primary completion date June 14, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 45 Years
Eligibility 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

Study Design


Intervention

Drug:
Cannabis
Participants will smoke as much of the cigarette as they wish
Placebo
Participants will smoke a placebo cigarette

Locations

Country Name City State
Canada Center for Addiction and Mental Health Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean speed Speed of driving the simulator Change in speed of driving between the time before smoking the cigarette and either 30 or 90 minutes after smoking the cigarette
Secondary Standard deviation of lateral position Driving measures Change in measure from before smoking the cigarette to either 30 or 90 minutes after smoking
Secondary reaction time Driving measures Change in measure from before smoking the cigarette to either 30 or 90 minutes after smoking
Secondary Blood concentrations of THC and metabolites Blood will be taken to determine how much THC entered the blood 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
Secondary Oral fluid concentrations of THC and metabolites Participants will provide oral fluid to determine how much THC is in the oral fluid Change from levels before smoking to 4 time points after smoking: 30 minutes, 90 minutes, 2 hours and 6 hours
Secondary Systolic and Diastolic Blood pressure Vital signs 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
Secondary Heart rate Vital signs 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
Secondary Respirations Vital signs 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
Secondary Temperature Vital signs 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
Secondary 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' 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
Secondary Verbal free recall test Test of memory: Participants will be asked to recall words that are read from a list Change from pre-smoking levels to those observed 60 minutes after smoking
Secondary Useful field of view A computer test for visual processing speed, selective and divided attention Change from pre-smoking levels to those observed 60 minutes after smoking
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