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| Name | Class |
|---|---|
| Dicentra Inc. | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gaize Device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Recognition Expert Protocol Eye Test Scores | Correlation between scores at baseline and post cannabis consumption (10 min, 30 min, 60 min, 90 min) | up to 90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Fichtler | Gaize | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dicentra | Toronto | Ontario | M5S 2B7 | Canada |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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