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Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04799093
Recruitment Status : Completed
First Posted : March 16, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Oculogica, Inc.

Study Description
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Brief Summary:
The purpose of this study is to determine the accuracy of an impairment algorithm based on eye tracking while watching a short film clip, in comparison to a clinical reference standard of impairment.

Condition or disease Intervention/treatment
Impairment Cannabis Intoxication Diagnostic Test: EyeBOX

Study Design
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Study Type : Observational
Actual Enrollment : 225 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication
Actual Study Start Date : February 1, 2021
Actual Primary Completion Date : September 7, 2021
Actual Study Completion Date : September 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Groups and Cohorts
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Group/Cohort Intervention/treatment
Cannabis users Diagnostic Test: EyeBOX
Eye-Tracking based diagnostic
Normals Diagnostic Test: EyeBOX
Eye-Tracking based diagnostic


Outcome Measures
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Primary Outcome Measures :
  1. Impairment assessment correlation with EyeBOX assessment [ Time Frame: Within an hour ]
    A correlation between impairment as assessed by standard impairment tests and the EyeBOX assessment of impairment as determined by an algorithm.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy habitual cannabis-smoking subjects, i.e., smoke or consume cannabis at least three times a week, and healthy occasional cannabis-smoking subjects, i.e., smoke or consume once a week will be recruited from the local area.
Criteria

Inclusion Criteria:

  1. Provide written informed consent.
  2. Have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking.
  3. Be at least 18 years old.

Exclusion Criteria:

  1. Be blind (no light perception), have missing or non-functional eyes.
  2. Be unable to open their eyes.
  3. Have a history of unresolved strabismus, diplopia, amblyopia.
  4. Have a history of unresolved cranial nerve III, IV, or VI palsy.
  5. Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
  6. Have a history of extensive prior eye surgery (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions) or scarring.
  7. Have a prior history of unresolved ocular-motor dysfunctions.
  8. Have used cannabis, alcohol etc. 24 hours before study commences.
  9. Be 100% naïve to cannabis usage.
  10. Be pregnant.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04799093


Locations
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United States, Connecticut
Integrated Medicine LLC
Westport, Connecticut, United States, 06880
Sponsors and Collaborators
Oculogica, Inc.
Investigators
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Study Director: Rosina Samadani, Ph.D. Oculogica, Inc.
More Information
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Responsible Party: Oculogica, Inc.
ClinicalTrials.gov Identifier: NCT04799093    
Other Study ID Numbers: CAN-B
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders