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Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment

Primary Purpose

Cannabis Intoxication

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-Eye
Cannabis cigarette - 4.0% THC
Sponsored by
Battelle Memorial Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Cannabis Intoxication focused on measuring cannabis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Battelle Memorial Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Directed smoking of about 3.6% THC cannabis cigarette

Outcomes

Primary Outcome Measures

Change from baseline in Pupil Dilation
Change in pupil dilation in different lights will be measured by the eye tracking sensor
Change from baseline in Gaze Nystagmus
Change in Gaze Nystagmus will be measured by the eye tracking sensor
Change from baseline in Lack of Convergence
Change in Lack of Convergence will be measured by the eye tracking sensor

Secondary Outcome Measures

Plasma THC
Plasma concentration before and after smoking
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.
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.
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.

Full Information

First Posted
June 12, 2019
Last Updated
September 27, 2021
Sponsor
Battelle Memorial Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03994926
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 Pandmic halted study
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Battelle Memorial Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Intoxication
Keywords
cannabis

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Directed smoking of about 3.6% THC cannabis cigarette
Intervention Type
Device
Intervention Name(s)
Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-Eye
Intervention Description
Device measures smooth eye pursuit and response to light flash after pt smokes cannabis
Intervention Type
Drug
Intervention Name(s)
Cannabis cigarette - 4.0% THC
Other Intervention Name(s)
Marijuana
Intervention Description
smoked cannabis 4.0% THC
Primary Outcome Measure Information:
Title
Change from baseline in Pupil Dilation
Description
Change in pupil dilation in different lights will be measured by the eye tracking sensor
Time Frame
Before and after smoking (up to 240 minutes)
Title
Change from baseline in Gaze Nystagmus
Description
Change in Gaze Nystagmus will be measured by the eye tracking sensor
Time Frame
Before and after smoking (up to 240 minutes)
Title
Change from baseline in Lack of Convergence
Description
Change in Lack of Convergence will be measured by the eye tracking sensor
Time Frame
Before and after smoking (up to 240 minutes)
Secondary Outcome Measure Information:
Title
Plasma THC
Description
Plasma concentration before and after smoking
Time Frame
Before and after smoking (9 timepoints up to 240 minutes post smoking)
Title
Change from baseline in Cannabis Subjective Effects
Description
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.
Time Frame
Before and after smoking (up to 240 minutes post smoking)
Title
Change from baseline in Four Choice Reaction Time Task
Description
Will assess changes in psychomotor/cognitive performance known to be sensitive to the acute effects of smoked cannabis.
Time Frame
Before and after smoking (up to 240 minutes post smoking)
Title
Change from baseline in Digit Symbol Substitution Task
Description
Will assess changes in psychomotor/cognitive performance known to be sensitive to the acute effects of smoked cannabis.
Time Frame
Before and after smoking (up to 240 minutes post smoking)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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; 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) Previously reported negative effects from the use of VR goggles or negative effects from the use of VR goggles during screening
Facility Information:
Facility Name
Battelle Memorial Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
4696937
Citation
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.
Results Reference
background
PubMed Identifier
25745105
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.
Results Reference
background
PubMed Identifier
15319805
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.
Results Reference
background
PubMed Identifier
9260070
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.
Results Reference
background

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Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment

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