Cannabis Impairment Detection Device Study

Not Applicable

Completed

• Conditions: Cannabis Intoxication

• Registration Number: NCT07122349
• Lead Sponsor: Gaize

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-08
• Primary Completion: 2022-10-24
• Study Completion: 2022-10-24
• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of device/procedure related Adverse Events/Serious Adverse Events during study intervention	Immediately after testing.	Number of participants experiencing complications related to the investigational device (headache, dizziness, nausea, etc.)

Secondary Outcome Measures

Name	Time	Method
Drug Recognition Expert Protocol Eye Test Scores	up to 90 minutes	Correlation between scores at baseline and post cannabis consumption (10 min, 30 min, 60 min, 90 min)

Trial Locations

Locations (1)

Dicentra; 🇨🇦 Toronto, Ontario, Canada