Clinical trial NCT03813602: Detection of Cannabis Impairment With an Eye Tracker
Official title: Effects of Cannabis on Driver Performance and Eye Movements and Characteristics During Simulated Driving: Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cannabis Intoxication
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Cannabis is one of the widely used psychoactive substances in the world. With increasing legalization, the prevalence of driving under the influence of cannabis will undoubtedly rise. At present, roadside detection of cannabis intoxication is largely dependent on drug recognition experts who rely on changes in eye movements when impaired. In this regard, use of eye trackers can help to detect impairment in drivers. The purpose of the present study is to determine the feasibility of the use of eye trackers in detecting impairment in participants who smoked a cannabis cigarette.

Detailed description: Participants will attend one study session after determination of eligibility. During this session, they will smoke a cannabis cigarette with 12.5% THC prior to driving a simulator. Driving will be assessed prior to smoking cannabis and at 7 time points after smoking cannabis. Eye tracking measures will also be taken while driving after smoking cannabis. Blood will be drawn for determination of levels of the psychoactive substance THC and its metabolites. Saliva tests, urine tests and subjective tests will also be performed at various times points after smoking cannabis.

Eligibility criteria: Inclusion Criteria:

* Weekly use of cannabis (1 to 4 days per week) confirmed by urine point-of-care testing;
* 19-26 years of age;
* holds a class G or G2 Ontario driver's licence (or equivalent from another jurisdiction) for at least 12 months;
* Willing to abstain from using alcohol for 48 hours and cannabis for 72 hours prior to the study session;
* Willing to abstain from all other drugs not prescribed for medical purposes for the duration of the study;
* Provides written and informed consent.

Exclusion Criteria:

* Urine toxicology screens negative for cannabis upon eligibility assessment;
* Diagnosis of severe medical or psychiatric conditions;
* Females: Pregnancy or breastfeeding;
* Meets criteria for Alcohol or Substance Dependence (current or lifetime) (DSM-IV);
* Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants);
* First-degree relative diagnosed with schizophrenia.

Primary outcomes:
measure: Change in eye gaze
timeFrame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary outcomes:
measure: Change in saccades
timeFrame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in eye fixations
timeFrame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in blinking rate
timeFrame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in blinking duration
timeFrame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in blinking speed
timeFrame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in pupil size
timeFrame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in mean speed on the driving simulator
timeFrame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in standard deviation of speed on the driving simulator
timeFrame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in maximum speed on the driving simulator
timeFrame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in standard deviation of lateral position on the driving simulator
timeFrame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in minimum time to collision on the driving simulator
timeFrame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in number of collisions
timeFrame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in blood concentrations of delta-9-tetrahydrocannabinol
timeFrame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in blood concentrations of carboxy-tetrahydrocannabinol
timeFrame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in blood concentrations of 11-hydroxy-tetrahydrocannabinol
timeFrame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in saliva THC detection
timeFrame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in systolic blood pressure
timeFrame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in diastolic blood pressure
timeFrame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in heart rate
timeFrame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in temperature
timeFrame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in number of respirations per minute
timeFrame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
measure: Change in Subjective cannabis effects with a visual analog scale
timeFrame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addition and Mental Health
name: Bernard Le Foll, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shahidi Zandi A, Comeau FJE, Mann RE, Di Ciano P, Arslan EP, Murphy T, Le Foll B, Wickens CM. Preliminary Eye-Tracking Data as a Nonintrusive Marker for Blood Delta-9-Tetrahydrocannabinol Concentration and Drugged Driving. Cannabis Cannabinoid Res. 2021 Dec;6(6):537-547. doi: 10.1089/can.2020.0141. Epub 2021 Aug 24.