Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment

NCT03994926 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: 131310
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

Cannabis Intoxication

Keywords

cannabis

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (4)

• Plasma THC

  Before and after smoking (9 timepoints up to 240 minutes post smoking)

• Change from baseline in Cannabis Subjective Effects

  Before and after smoking (up to 240 minutes post smoking)

• Change from baseline in Four Choice Reaction Time Task

  Before and after smoking (up to 240 minutes post smoking)

• Change from baseline in Digit Symbol Substitution Task

  Before and after smoking (up to 240 minutes post smoking)

Study Arms (1)

Experimental

EXPERIMENTAL

Directed smoking of about 3.6% THC cannabis cigarette

Device: Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-Eye; Drug: Cannabis cigarette - 4.0% THC

Interventions

Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-Eye DEVICE

Device measures smooth eye pursuit and response to light flash after pt smokes cannabis

Experimental

Cannabis cigarette - 4.0% THC DRUG

smoked cannabis 4.0% THC

Also known as: Marijuana

Experimental

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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;
• 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;
• Investigator discretion due to use of caffeine, over-the-counter (OTC) drugs, prescription drugs, alcohol, or physical/mental health history;
• Positive urine drug screen for drugs included on the urine drug panel other than cannabis;
• Acute illness (such as cold or flu) which will require participant to be rescheduled, if authorized by study PI;
• Vital signs thought to be clinically significant by licensed medical professional;
• Self-reported history or medical evidence of prior intravenous drug use; and
• Investigator discretion due to medical, mental health, or substance use history.
• Presence of implanted devices in the body (pacemaker etc)

Sponsors & Collaborators

• Battelle Memorial Institute: lead

Study Sites (1)

Battelle Memorial Institute

Baltimore, Maryland, 21209, United States

Location

Related Publications (4)

• Casswell S, Marks D. Cannabis induced impairment of performance of a divided attention task. Nature. 1973 Jan 5;241(5384):60-1. doi: 10.1038/241060b0. No abstract available.

  PMID: 4696937 BACKGROUND

• 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.

  PMID: 25745105 BACKGROUND

• 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.

  PMID: 15319805 BACKGROUND

• 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.

  PMID: 9260070 BACKGROUND

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol; nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 21, 2019
• Study Start: February 3, 2020
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)