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Completed

NCT Number: NCT07122349

Cannabis Impairment Detection Device Study

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.

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Key information

Conditions

Cannabis Intoxication Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dicentra

Toronto, Ontario, M5S 2B7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cannabis Impairment Test

Device

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.

Primary outcomes

  1. Incidence of device/procedure related Adverse Events/Serious Adverse Events during study intervention

    Time frame: Immediately after testing.

    Number of participants experiencing complications related to the investigational device (headache, dizziness, nausea, etc.)

Secondary outcomes

  1. Drug Recognition Expert Protocol Eye Test Scores

    Time frame: up to 90 minutes

    Correlation between scores at baseline and post cannabis consumption (10 min, 30 min, 60 min, 90 min)

Sponsors and collaborators

Lead sponsor

Gaize

Industry

Collaborators

  • Dicentra Inc.

Registry information

Official study title

An Interventional Study to Facilitate the Development of a Cannabis Impairment Detection Device in Adult Cannabis Users

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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