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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03994926
Other study ID # 131310
Secondary ID
Status Terminated
Phase Early Phase 1
First received
Last updated
Start date February 3, 2020
Est. completion date March 13, 2020

Study information

Verified date September 2021
Source Battelle Memorial Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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 - 4.0% THC
smoked cannabis 4.0% THC

Locations

Country Name City State
United States Battelle Memorial Institute Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Battelle Memorial Institute

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Outcome

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)
See also
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Recruiting NCT04931095 - The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment Phase 1
Completed NCT04799093 - Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication
Not yet recruiting NCT06293040 - Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment Phase 1
Withdrawn NCT05273658 - Effects of Cannabis/Alcohol on Driving Performance and Field Sobriety Tests Phase 1/Phase 2
Completed NCT03813602 - Detection of Cannabis Impairment With an Eye Tracker Phase 1/Phase 2
Not yet recruiting NCT04855526 - THC + CBD and Memory Study Early Phase 1