Cannabis IntoxicationNCT07122349
Cannabis Impairment Detection Device Study
A study testing Cannabis Impairment Test in people with Cannabis Intoxication, run by Gaize at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis Intoxication
- What is being tested?
- Cannabis Impairment Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteCanada
- Study dates
- 8 Sep 2022to 24 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional Study to Facilitate the Development of a Cannabis Impairment Detection Device in Adult Cannabis Users
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.
- Conditions
- Cannabis Intoxication
- Being tested
- Cannabis Impairment Test
- Keywords
- Cannabis, Marijuana, Intoxication, Impairment, Eye Test, Ocular, Drug
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis Impairment TestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Gaize Device | Experimental | Not described Receives: Device: Cannabis Impairment Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: Immediately after testing.
Secondary outcomes (1)
Drug Recognition Expert Protocol Eye Test Scores
Correlation between scores at baseline and post cannabis consumption (10 min, 30 min, 60 min, 90 min)
Measured: up to 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start8 Sep 2022
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis IntoxicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaize
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dicentra Inc.
- Responsible party
- Sponsor
- Investigators
- Ken Fichtler, Study chair, Gaize
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122349
- Sponsor's protocol ID
- 22-GPHCV-01
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study to Facilitate the Development of a Cannabis Impairment Detection Device in Adult Cannabis Users
- ClinicalTrials.gov ID
- NCT07122349
- Acronym / sponsor ID
- 22-GPHCV-01
- Conditions
- Cannabis Intoxication
- Keywords
- Cannabis, Marijuana, Intoxication, Impairment, Eye Test, Ocular, Drug
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- GaizeIndustry (pharma, biotech, devices)
- Collaborators
- Dicentra Inc.
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gaize Device | Experimental | Device: Cannabis Impairment Test |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis Impairment TestAutomated 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. | Device | Gaize Device |
Primary outcome
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.)
1 secondary outcome
Drug Recognition Expert Protocol Eye Test Scores
Time frame: up to 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Fichtler study chair
Gaize
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabis Impairment Test in people with Cannabis Intoxication, run by Gaize at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of device/procedure related Adverse Events/Serious Adverse Events during study intervention (time frame: Immediately after testing.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.