Detection of Cannabis Impairment With an Eye Tracker | NCT03813602

Studies
Detection of Cannabis Impairment With an Eye Tracker

NCT03813602

Sponsor

Centre for Addiction and Mental Health

Status

Completed

Last Update Posted

Dec 12, 2019Actual

Enrollment

10Actual

Phase

Phase 1Phase 2

Conditions

Cannabis Intoxication

Interventions

Cannabis Sativa

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2019Actual

Primary Completion Date

Nov 15, 2019Actual

Completion Date

Nov 15, 2019Actual

First Submitted Date

Jan 16, 2019

First Submission Date that Met QC Criteria

Jan 18, 2019

First Posted Date

Jan 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2019

Last Update Posted Date

Dec 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cannabis sativa	Experimental	a 750 mg cannabis cigarette with 12.5% THC	Drug: Cannabis Sativa

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cannabis Sativa	Drug	750 mg cannabis cigarette with 12.5% THC	Cannabis sativa

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Change in eye fixations	Measure of where the eye is looking with an eye tracker

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

26 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernard Le Foll, MD PhD	Centre for Addition and Mental Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Addiction and Mental Health		Toronto	Ontario	M5S 2S1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34432541	Derived	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.