Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment

NCT ID: NCT03994926

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-03
• Study Completion Date: 2020-03-13

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.

Conditions

Cannabis Intoxication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Experimental

Directed smoking of about 3.6% THC cannabis cigarette

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Cannabis cigarette - 4.0% THC

Intervention Type: DRUG

smoked cannabis 4.0% THC

Interventions

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

Intervention Type: DEVICE

Cannabis cigarette - 4.0% THC

smoked cannabis 4.0% THC

Intervention Type: DRUG

Other Intervention Names

Marijuana

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Battelle Memorial Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Battelle Memorial Institute

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 4696937 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25745105 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15319805 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9260070 (View on PubMed)

Other Identifiers

131310

Identifier Type: -

Identifier Source: org_study_id