Clinical trial NCT03994926: Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment
Official title: Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Cannabis Intoxication
Keywords: cannabis
Lead sponsor: Battelle Memorial Institute
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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).

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 4.0% THC) cannabis cigarette. Assessments will be collected after-cannabis smoking up to 4 hours. Participants will be sent home from the laboratory via taxi.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Currently living in Baltimore City or Baltimore County, MD, or Investigator discretion;
3. Able to read, understand, and sign informed consent;
4. 18-55 years old;
5. Self-reports lifetime smoking of cannabis at least 10 times without any negative side effects;
6. Self-reports past-year smoking of cannabis at least 1 time but no more than 2 days per week on average;
7. Designation of Medically Healthy for Research by the Study Physician.
8. Agree to abstain from consuming alcohol for 10 hours and marijuana for 72 hour prior to the study visit

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.
15. Presence of implanted devices in the body (pacemaker etc)
16. Previously reported negative effects from the use of VR goggles or negative effects from the use of VR goggles during screening

Primary outcomes:
measure: Change from baseline in Pupil Dilation
timeFrame: Before and after smoking (up to 240 minutes)
measure: Change from baseline in Gaze Nystagmus
timeFrame: Before and after smoking (up to 240 minutes)
measure: Change from baseline in Lack of Convergence
timeFrame: Before and after smoking (up to 240 minutes)
Secondary outcomes:
measure: Plasma THC
timeFrame: Before and after smoking (9 timepoints up to 240 minutes post smoking)
measure: Change from baseline in Cannabis Subjective Effects
timeFrame: Before and after smoking (up to 240 minutes post smoking)
measure: Change from baseline in Four Choice Reaction Time Task
timeFrame: Before and after smoking (up to 240 minutes post smoking)
measure: Change from baseline in Digit Symbol Substitution Task
timeFrame: Before and after smoking (up to 240 minutes post smoking)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Battelle Memorial Institute
state: Maryland
Study officials:
References:
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citation: Desrosiers NA, Ramaekers JG, Chauchard E, Gorelick DA, Huestis MA. Smoked cannabis' psychomotor and neurocognitive effects in occasional and frequent smokers. J Anal Toxicol. 2015 May;39(4):251-61. doi: 10.1093/jat/bkv012. Epub 2015 Mar 4.
citation: Murillo R, Crucilla C, Schmittner J, Hotchkiss E, Pickworth WB. Pupillometry in the detection of concomitant drug use in opioid-maintained patients. Methods Find Exp Clin Pharmacol. 2004 May;26(4):271-5.
citation: Pickworth WB, Rohrer MS, Fant RV. Effects of abused drugs on psychomotor performance. Exp Clin Psychopharmacol. 1997 Aug;5(3):235-41. doi: 10.1037//1064-1297.5.3.235.