Dose-response of Cannabis and Driving

NCT03656029 | Completed Phase 2

• 1 other identifier: 007-2018
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Driving Impaired; Cognitive Impairment; Abuse Cannabis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Standard deviation of lateral position

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

• reaction time

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

• Blood concentrations of THC and metabolites

  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

  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

  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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

low dose

ACTIVE COMPARATOR

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

Drug: Cannabis

middle dose

ACTIVE COMPARATOR

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

Drug: Cannabis

high dose

ACTIVE COMPARATOR

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

Drug: Cannabis

Interventions

Cannabis DRUG

Participants will smoke as much of the cigarette as they wish

high dose; low dose; middle dose

Placebo DRUG

Participants will smoke a placebo cigarette

Placebo

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Center for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Bruna Brands, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: September 4, 2018
• Study Start: June 4, 2021
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)