Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment (NCT03994926) | Clinical Trial Compass
TerminatedEarly Phase 1
Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment
Stopped: COVID-19 Pandmic halted study
United States3 participantsStarted 2020-02-03
Plain-language 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).
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Willing to sign a confidentiality agreement stating the will not discuss study specifics, information or materials presented to them in the study with those not involved in the study;
✓. Currently living in Baltimore City or Baltimore County, MD, or Investigator discretion;
✓. Able to read, understand, and sign informed consent;
✓. 18-55 years old;
✓. Self-reports lifetime smoking of cannabis at least 10 times without any negative side effects;
✓. Self-reports past-year smoking of cannabis at least 1 time but no more than 2 days per week on average;
✓. Designation of Medically Healthy for Research by the Study Physician.
✓. Agree to abstain from consuming alcohol for 10 hours and marijuana for 72 hour prior to the study visit
Exclusion criteria
✕. BAC \> 0.020% as measured by alcohol breathalyzer;
✕. Meets DSM-5 criteria for any current Axis I disorder other than mild or moderate Cannabis Use Disorder;
✕. 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;
✕. 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;
What they're measuring
1
Change from baseline in Pupil Dilation
Timeframe: Before and after smoking (up to 240 minutes)
2
Change from baseline in Gaze Nystagmus
Timeframe: Before and after smoking (up to 240 minutes)
3
Change from baseline in Lack of Convergence
Timeframe: Before and after smoking (up to 240 minutes)
✕. Has difficulties with blood draws or poor venous access;
✕. History of blood donation in the past 30 days or receiving blood products within the past 2 months prior to any experimental visit;
✕. Investigator discretion due to self-reported use of medical cannabis or using cannabis for self-medication;
✕. 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;