Detection of Cannabis Impairment With ISBRG's SpotLight-THC

Subjects will participate in a 2-visit study protocol in which they will be administered cannabis of pre-determined concentrations and asked to complete a simulated drive in a driving simulator. Subjects will be scanned on two SpotLight-THC (Alpha and Beta iterations) devices and peripheral venous whole blood will be collected from subjects for analysis on up to four occasions on each visit.

The purpose of the investigation will be to determine whether the SpotLight-THC device is a reliable measure of THC impairment at the roadside, with an objective to identify a unique blood analyte architecture for THC impairment using near infrared light and machine learning.

Study Overview

• Status: Recruiting
• Conditions: Cannabis
• Intervention / Treatment: Drug: Cannabis(THC) inhaled

Detailed Description

At the University of Iowa, subjects who currently use cannabis recreationally will be recruited. They will then undergo a screening visit in which consent is obtained, questionnaires are given, a physical exam is conducted and subjects will use the driving simulator to assess propensity to sickness and to familiarize them with the simulation. They will then be scheduled for their next visit. At the second visit, subjects will be administered 5-10% THC. A series of baseline tests, including a test requiring a blood sample will be administered upon arrival. After drug administration, subjects will be asked to complete a set of verbal recall questions followed by three simulated driving trials, completing 7 non-invasive SpotLight-19 scans (20 seconds x 2) and 3 blood samples throughout the visit.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rose A Schmitt, B.S.; Phone Number: 319-335-4666; Email: rose-potter@uiowa.edu
• Study Contact Backup: Name: Timothy L Brown, Ph.D.; Phone Number: 319-335-4785; Email: timothy-l-brown@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • National Advanced Driving Simulator
      • Contact: Rose A Schmitt, B.S.; Phone Number: 319-335-4666; Email: rose-potter@uiowa.edu
      • Contact: Timothy L Brown, Ph.D.; Phone Number: 319-335-4785; Email: timothy-l-brown@uiowa.edu
      • Principal Investigator: Timothy L Brown, Ph.D.
      • Sub-Investigator: Gary R Gaffney, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults aged at least 18 years old
• Must self-report use of cannabis at least once a month
• Has held a valid driver's license at least 12 months
• Must be willing to abstain from using cannabis and alcohol for 24 hours prior to each session
• Must be willing to abstain from all other drugs not medically required for duration of the study (beginning 24 hours prior to the screening visit)
• Must be able to drive without special or non-standard equipment
• Must be able to meet study time commitment
• Provides written and informed consent

Exclusion Criteria:

• Diagnosis of severe medical or psychiatric condition (as judged by study physician)
• Evidence of substance use disorder as reflected by total scores on DUDIT and AUDIT
• Regular user of medication that may affect cognitive functioning and/or driver performance (e.g., antidepressants, benzodiazepines, stimulants, opioids) as judged by study physician
• Family history of schizophrenia or other psychotic disorder (or taking medications for such)
• Pregnant or test positive for pregnancy, looking to become pregnant, or breastfeeding
• Respiratory or pulmonary disorder that would negatively affect ability to inhale and hold the cannabis dose
• Recent (past 6 months) head injury or stroke, or current symptoms from prior head injury or stroke
• History of heart disease, angina, heart attack, heart surgery, or myocardial infarction (or taking medications for such)
• Untreated/Untreatable vision or auditory issues (because testing currently requires both senses)
• History of suicidal behaviors in past two years
• Excessive tobacco use (more than 10 cigarettes a day or 3 or more cigars or pipes per day)
• Excessive caffeine use (6 or more servings per day)
• Excessive alcohol (14 or more drinks per week)
• Regular use of pain medications other than OTC
• Use of prescription drugs not prescribed to them or illicit drugs other than cannabis
• History of substance abuse or substance addiction
• Expressed interest in or participation in drug abuse treatment in past 60 days
• Currently diagnosed cannabis use disorder
• History of negative reaction to cannabis
• Extreme scarring on fingertips that prevents use of the device
• Participation in night shift work

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baseline followed by 5-10% THC Validation	Drug: Cannabis(THC) inhaled; Cannabis vapor is produced from 500mg, approximately 5-10% High dose bulk cannabis plant material, 30-37.5 mg THC
Experimental: Baseline followed by 5-10% THC Verification	Drug: Cannabis(THC) inhaled; Cannabis vapor is produced from 500mg, approximately 5-10% High dose bulk cannabis plant material, 30-37.5 mg THC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Acute Subjective Response to Cannabis Score	The total score of the true responses (true/false scale, minimum score is 0 with a maximum score of 12). A higher score indicates greater drug effect. Used to determine subjective level of drug effect.	At baseline, 20, 30, 60, 90, 120 and 180 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard Deviation of Lateral Position (SDLP) - Undistracted	The ability to keep the vehicle straight in the lane and the corresponding data is presented from a rural drive without any secondary tasks relative to the 20 minute baseline drive pre dose.	Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose
Standard Deviation of Lateral Position (SDLP) - Distracted	The ability to keep the vehicle straight in the lane and the corresponding data is presented from a rural drive while engaged in a secondary task relative to the 20 minute baseline drive while engaged in the same task pre dose.	Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose
Blood Delta-9-THC	THC concentration levels of Delta-9-THC in whole blood.	At baseline, 20, 90, and 180 minutes

Collaborators and Investigators

• Sponsor: ISBRG Corp
• Collaborators: National Advanced Driving Simulator
• Investigators: Principal Investigator: Timothy L Brown, Ph.D., National Advanced Driving Simulator

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: THC; Driving under the influence; Cannabis impairment; SpotLight-THC; Non-invasive detection; ISBRG
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: 202108451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No