Detection of Cannabis Impairment With an Eye Tracker

Cannabis Intoxication Clinical Trial

— ACS  

Official title:

Effects of Cannabis on Driver Performance and Eye Movements and Characteristics During Simulated Driving: Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03813602
• Other study ID #: 076/2018
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 15, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: December 2019
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Intoxication
• Marijuana Abuse

Intervention

Drug:
• Cannabis Sativa
750 mg cannabis cigarette with 12.5% THC

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	Change in eye gaze	Measures of eye movement with an eye tracker	baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in saccades	Measures of quick eye movements with an eye tracker	baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in eye fixations	Measure of where the eye is looking with an eye tracker	baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in blinking rate	The number of blinks, measured with an eye tracker	baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in blinking duration	The length of time that blinks last, measured with a eye tracker	baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in blinking speed	How fast the blinking is, measured with an eye tracker	baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in pupil size	The diameter of pupils while driving, measured with an eye tracker	baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in mean speed on the driving simulator	The speed, in km, while driving a driving simulator	baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in standard deviation of speed on the driving simulator	The amount of variation in speed while driving the driving simulator	baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in maximum speed on the driving simulator	The greatest speed obtained on the driving simulator	baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in standard deviation of lateral position on the driving simulator	The amount of weaving while driving the driving simulator	baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in minimum time to collision on the driving simulator	The time needed to collide with the car in front, while driving the simulator	baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in number of collisions	The number of times a car impacts another car while driving the simulator	baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in blood concentrations of delta-9-tetrahydrocannabinol	The levels of the psychoactive component of cannabis, THC, in blood	baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in blood concentrations of carboxy-tetrahydrocannabinol	The levels of the inactive metabolite of THC in blood	baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in blood concentrations of 11-hydroxy-tetrahydrocannabinol	The levels of the active metabolite of THC in blood	baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in saliva THC detection	Detection of THC in saliva	baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in systolic blood pressure	Vital signs	baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in diastolic blood pressure	Vital signs	baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in heart rate	Vital signs	baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in temperature	Vital signs	baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in number of respirations per minute	Vital signs	baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary	Change in Subjective cannabis effects with a visual analog scale	The amount of liking of cannabis from 0 to 100, with 100 being the greatest value	baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours