Cannabis Intoxication Clinical Trial
Official title:
Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment
Verified date | September 2021 |
Source | Battelle Memorial Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 3 |
Est. completion date | March 13, 2020 |
Est. primary completion date | March 13, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Battelle Memorial Institute | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Battelle Memorial Institute |
United States,
Casswell S, Marks D. Cannabis induced impairment of performance of a divided attention task. Nature. 1973 Jan 5;241(5384):60-1. — View 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. — View 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. — View Citation
Pickworth WB, Rohrer MS, Fant RV. Effects of abused drugs on psychomotor performance. Exp Clin Psychopharmacol. 1997 Aug;5(3):235-41. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Pupil Dilation | Change in pupil dilation in different lights will be measured by the eye tracking sensor | Before and after smoking (up to 240 minutes) | |
Primary | Change from baseline in Gaze Nystagmus | Change in Gaze Nystagmus will be measured by the eye tracking sensor | Before and after smoking (up to 240 minutes) | |
Primary | Change from baseline in Lack of Convergence | Change in Lack of Convergence will be measured by the eye tracking sensor | Before and after smoking (up to 240 minutes) | |
Secondary | Plasma THC | Plasma concentration before and after smoking | Before and after smoking (9 timepoints up to 240 minutes post smoking) | |
Secondary | Change from baseline in Cannabis Subjective Effects | 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. | Before and after smoking (up to 240 minutes post smoking) | |
Secondary | Change from baseline in Four Choice Reaction Time Task | Will assess changes in psychomotor/cognitive performance known to be sensitive to the acute effects of smoked cannabis. | Before and after smoking (up to 240 minutes post smoking) | |
Secondary | Change from baseline in Digit Symbol Substitution Task | Will assess changes in psychomotor/cognitive performance known to be sensitive to the acute effects of smoked cannabis. | Before and after smoking (up to 240 minutes post smoking) |
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