Cannabis Impairment Detection Device Study
An Interventional Study to Facilitate the Development of a Cannabis Impairment Detection Device in Adult Cannabis Users
1 other identifier
interventional
362
1 country
1
Brief Summary
The goal of this study is to develop a cannabis impairment detection device in adult cannabis users. The main question\[s\] it aims to answer are:
- Is the investigational device accurate and reliable at detecting cannabis impairment?
- is the device safe for the collection of eye movement data from cannabis intoxicated individuals? Participants will be administered a series of Drug Recognition Expert Ocular Tests via the Gaize headset following cannabis consumption.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2022
CompletedFirst Submitted
Initial submission to the registry
August 6, 2025
CompletedFirst Posted
Study publicly available on registry
August 14, 2025
CompletedAugust 17, 2025
August 1, 2025
2 months
August 6, 2025
August 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of device/procedure related Adverse Events/Serious Adverse Events during study intervention
Number of participants experiencing complications related to the investigational device (headache, dizziness, nausea, etc.)
Immediately after testing.
Secondary Outcomes (1)
Drug Recognition Expert Protocol Eye Test Scores
up to 90 minutes
Study Arms (1)
Gaize Device
EXPERIMENTALInterventions
Automated Drug Recognition Expert Ocular Tests administered via VR Headset, includes test for Lack of Smooth Pursuit, Horizontal and Vertical Gaze Nystagmus, Lack of Convergence, and Pupillary Rebound Dilation. Tests are preceded by an automated system calibration process.
Eligibility Criteria
You may qualify if:
- Adults 19, years or older, having given written informed consent to participate in the research trial and certifying that they will not drive for a period of at least 6 hours post discharge.
- Having used cannabis at least one time prior
- Having access to legal cannabis
- Normal or corrected to normal vision using either glasses or contact lenses, or surgery.
You may not qualify if:
- Enrolled in, or participated in another clinical trial within 30 days before the study
- Having a prosthetic eye
- Blood pressure greater than 160/90 mmHg and heart rate greater than 100 bpm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gaizelead
- Dicentra Inc.collaborator
Study Sites (1)
Dicentra
Toronto, Ontario, M5S 2B7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ken Fichtler
Gaize
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2025
First Posted
August 14, 2025
Study Start
September 8, 2022
Primary Completion
October 24, 2022
Study Completion
October 24, 2022
Last Updated
August 17, 2025
Record last verified: 2025-08