Detection of Cannabis Impairment With an Eye Tracker

NCT03813602 | Completed Phase 1

• 1 other identifier: 076/2018
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Intoxication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Change in saccades

  baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours

• Change in eye fixations

  baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours

• Change in blinking rate

  baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours

• Change in blinking duration

  baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours

• Change in blinking speed

  baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours

Study Arms (1)

Cannabis sativa

EXPERIMENTAL

a 750 mg cannabis cigarette with 12.5% THC

Drug: Cannabis Sativa

Interventions

Cannabis Sativa DRUG

750 mg cannabis cigarette with 12.5% THC

Also known as: Marijuana

Cannabis sativa

Eligibility Criteria

• Age: 19 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Weekly use of cannabis (1 to 4 days per week) confirmed by urine point-of-care testing;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Center for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (1)

• 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.

  PMID: 34432541 DERIVED

MeSH Terms

Interventions

nabiximols

Study Officials

• Bernard Le Foll, MD PhD

  Centre for Addition and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 23, 2019
• Study Start: August 15, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

CA (1)