Clinical trial NCT06595576: Cannabis Edibles and Simulated Driving
Official title: Dose-dependent Effects of Cannabis Edibles on Simulated Driving Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis
Driving Under the Influence
Keywords: Cannabis Edibles
THC
Driving Simulator
Cognition
Subjective Effects
Cannabinoids
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study will be a within-subjects, double-blind, placebo-controlled, randomized and counterbalanced human laboratory experiment assessing the effects of a range of doses of cannabis edibles on driving simulator performance. These 4 drug exposure conditions are: placebo, low dose (2 + 2% mg THC), medium dose (10 + 2% mg THC), and high dose (20 + 2% mg THC).
Primary purpose: OTHER

Brief summary: The goal of this human laboratory experiment is to determine the acute and residual effects of a range of doses of orally administered cannabis edibles on driving simulator performance in people who use cannabis recreationally. Four conditions will be tested: placebo, low dose, medium dose and high dose. Driving performance will be tested objectively using a driving simulator during a number of pre-programmed driving scenarios. The investigators will test the hypothesis that driving performance on a high-fidelity driving simulator will decrease with increasing doses of cannabis. Secondary objectives will:

* Determine the acute and residual (24 hour) cognitive, behavioural, and physiological effects of a range of doses of orally administered cannabis edibles on subjective effects, cognitive tests, verbal memory, and mood.
* Examine how the concentration of THC in blood and oral fluids correlates with driving simulator performance, as well as cognitive, behavioural, and physiological measures. Cannabinoid levels in blood, urine and oral fluids will be measured at baseline and over a 5 hour period following drug exposure. The investigators will examine the relationship between cannabinoid levels and performance measures in this time frame.
* Explore potential biomarkers of acute exposure to cannabis edibles by analyzing the following: circulating cell-free mtDNA (ccf-mtDNA), endocannabinoids, and metabolic biomarkers.


Eligibility criteria: Inclusion Criteria:

* Provides written and informed consent
* Stated the willingness to comply with all study procedures
* Recreational use of oral, vaped, smoked or edible cannabis (at least one day/week) and cannabis edibles (at least one day/month) confirmed by self-report and urine screening (i.e., positive THC result in point-of-care screening or Clinical Laboratory assay)
* Males and females aged 19 to 45 years
* Has held a class G license (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 practice or test 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)
* Lives within a radius that costs less than about $60 per taxi ride
* Able to consume the quantity of candies and drive the driving simulator as determined by a practice session
* A negative urine pregnancy test for those with childbearing potential
* Use of appropriate contraception for those with childbearing potential

Exclusion Criteria:

* Diagnosis of severe medical or psychiatric condition (e.g., diagnosis of a severe mood or anxiety disorder, based on self-report
* Meets criteria for current or lifetime alcohol or other substance use disorder (DSM-5), except tobacco use disorder and caffeine use disorder
* Regular user of medication that may affect cognitive functioning and/or driver performance (e.g. ADHD medication, benzodiazepines, stimulants, opioids)
* Regular user of illicit substances
* Personal or family history of schizophrenia or other psychotic disorder
* Pregnant, looking to become pregnant, or breastfeeding
* Concomitant therapy with sedative-hypnotics or other psychoactive drugs
* Severe laboratory abnormalities that could create safety issues based on the judgement of the Principal Investigator
* Cardiovascular or cerebrovascular disease
* Severe renal or liver disease
* Participation in another clinical or non-therapeutic study in the past month

Primary outcomes:
measure: Standard Deviation of Lateral Position (SDLP)
timeFrame: Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.
Secondary outcomes:
measure: Mean Speed (MS)
timeFrame: Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.
measure: Reaction Time (RT)
timeFrame: Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.
measure: Standard Deviation of Speed (SDS)
timeFrame: Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.
measure: Blood concentrations of Δ9-tetrahydrocannabinol (THC), 11-hydroxy-Δ9-tetrahydrocannabinol (OH-THC), and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH)
timeFrame: Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.
measure: Oral fluid concentrations of Δ9-tetrahydrocannabinol (THC), 11-hydroxy-Δ9-tetrahydrocannabinol (OH-THC), and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) and point-of-care detection of cannabinoids
timeFrame: Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.
measure: Heart Rate
timeFrame: Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing.
measure: Blood Pressure
timeFrame: Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing.
measure: Temperature
timeFrame: Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing.
measure: Visual Analog Scale (VAS)
timeFrame: Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing.
measure: Addiction Research Centre Inventory (ARCI)
timeFrame: Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.
measure: Profile of Mood States (POMS)
timeFrame: Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.
measure: Verbal Free Recall Task
timeFrame: Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.
measure: Blood Concentrations of mtDNA
timeFrame: Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.
measure: Blood Concentrations Endocannabinoids
timeFrame: Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Bernard Le Foll, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: