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Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment

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ClinicalTrials.gov Identifier: NCT03994926
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Battelle Memorial Institute

Brief Summary:
The purpose of this study is to determine if an eye tracking impairment sensor can detect cannabis-induced impairment after using cannabis.The overall objective is to correlate measures collected from the eye tracking sensor with measures related to cannabis impairment (e.g., plasma THC levels, self-reported cannabis subjective effects, cognitive effects).

Condition or disease Intervention/treatment Phase
Cannabis Intoxication Device: Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-Eye Drug: Cannabis cigarette - 3.6% THC Early Phase 1

Detailed Description:

The proposed project is a single-visit clinical laboratory study to evaluate the initial efficacy of an eye tracking sensor to detect cannabis-related impairment.

Participants will be experienced but not frequent cannabis users without evidence of heavy alcohol or illicit drug use or other physical or mental health illness. Participants will come in for one screening visit, and those who consent, are eligible, and enroll will complete one experimental laboratory session involving smoking of 50% of 1 active (approximately 3.6% THC) cannabis cigarette. Assessments will be collected after-cannabis smoking up to 4 hours. Participants will be sent home from the laboratory via taxi.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Experimental
Directed smoking of about 3.6% THC cannabis cigarette
Device: Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-Eye
Device measures smooth eye pursuit and response to light flash after pt smokes cannabis

Drug: Cannabis cigarette - 3.6% THC
smoked cannabis 3.6% THC
Other Name: Marijuana




Primary Outcome Measures :
  1. Change from baseline in Rebound Pupil Dilation [ Time Frame: Before and after smoking (up to 240 minutes) ]
    Change in rebound pupil dilation will be measured by an HTC Vive Eye-Pro

  2. Change from baseline in Horizontal Gaze Nystagmus [ Time Frame: Before and after smoking (up to 240 minutes) ]
    Change in Horizontal Gaze Nystagmus will be measured by an HTC Vive Eye-Pro

  3. Change from baseline in Lack of Convergence [ Time Frame: Before and after smoking (up to 240 minutes) ]
    Change in Lack of Convergence will be measured by an HTC Vive Eye-Pro


Secondary Outcome Measures :
  1. Plasma THC [ Time Frame: Before and after smoking (9 timepoints up to 240 minutes post smoking) ]
    Plasma concentration before and after smoking

  2. Change from baseline in Cannabis Subjective Effects [ Time Frame: Before and after smoking (up to 240 minutes post smoking) ]
    Scores for the question "do you feel a drug effect" are measured on a 0-100 point visual analogue scale to measure change in marijuana intoxication across timepoints.

  3. Change from baseline in Divided Attention Task [ Time Frame: Before and after smoking (up to 240 minutes post smoking) ]
    Will assess changes in psychomotor/cognitive performance known to be sensitive to the acute effects of smoked cannabis.

  4. Change from baseline in Digit Symbol Substitution Task [ Time Frame: Before and after smoking (up to 240 minutes post smoking) ]
    Will assess changes in psychomotor/cognitive performance known to be sensitive to the acute effects of smoked cannabis.

  5. Change from baseline in Paced Auditory Serial Addition Task [ Time Frame: Before and after smoking (up to 240 minutes post smoking) ]
    Will assess changes in psychomotor/cognitive performance known to be sensitive to the acute effects of smoked cannabis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Currently living in Baltimore City or Baltimore County, MD, or Investigator discretion;
  2. Able to read, understand, and sign informed consent;
  3. 18-55 years old;
  4. Self-reports lifetime use of cannabis at least 10 times without any negative side effects;
  5. Self-reports past-year use of cannabis at least 1 time but no more than 2 days per week on average;
  6. Designation of Medically Healthy for Research by the Study Physician.

Exclusion Criteria:

  1. BAC > 0.020% as measured by alcohol breathalyzer;
  2. Meets DSM-5 criteria for any current Axis I disorder other than mild or moderate Cannabis Use Disorder;
  3. Self-reported current desire to stop cannabis use, defined as 7 or greater on an 11-rung (scale of 0-10) on the Contemplation Ladder assessment;
  4. Self-reported current asthma, chronic obstructive pulmonary disease, hypertension, cardiovascular disease or any other medical illness that precludes participation based on the clinical judgment of the Study Physician and Investigative Team;
  5. Has difficulties with blood draws or poor venous access;
  6. History of blood donation in the past 30 days or receiving blood products within the past 2 months prior to any experimental visit;
  7. Investigator discretion due to self-reported use of medical cannabis or using cannabis for self-medication;
  8. Among females, current pregnancy or lactation or attempting to get pregnant, or at risk of becoming pregnant, as defined as being sexually active with a male partner and not willing to use a reliable form of contraception;
  9. Investigator discretion due to use of caffeine, over-the-counter (OTC) drugs, prescription drugs, alcohol, or physical/mental health history;
  10. Positive urine drug screen for drugs included on the urine drug panel other than cannabis;
  11. Acute illness (such as cold or flu) which will require participant to be rescheduled, if authorized by study PI;
  12. Vital signs thought to be clinically significant by licensed medical professional;
  13. Self-reported history or medical evidence of prior intravenous drug use; and
  14. Investigator discretion due to medical, mental health, or substance use history.

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): NCT03994926


Contacts
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Contact: Carson Smith, MPH, MPA 4103722705 smithc@battelle.org

Locations
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United States, Maryland
Battelle Memorial Institute
Baltimore, Maryland, United States, 21209
Sponsors and Collaborators
Battelle Memorial Institute

Publications:
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Responsible Party: Battelle Memorial Institute
ClinicalTrials.gov Identifier: NCT03994926     History of Changes
Other Study ID Numbers: 131310
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Battelle Memorial Institute:
cannabis
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders