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Detection of Cannabis Impairment With ISBRG's SpotLight-THC

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ClinicalTrials.gov Identifier: NCT05276232
Recruitment Status : Recruiting
First Posted : March 11, 2022
Last Update Posted : March 11, 2022
Sponsor:
Collaborator:
National Advanced Driving Simulator
Information provided by (Responsible Party):
ISBRG Corp

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cannabis Drug: Cannabis(THC) inhaled Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Detection of Cannabis Impairment With ISBRG's SpotLight-THC
Estimated Study Start Date : March 2022
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in Acute Subjective Response to Cannabis Score [ Time Frame: At baseline, 20, 30, 60, 90, 120 and 180 minutes ]
    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.


Secondary Outcome Measures :
  1. Standard Deviation of Lateral Position (SDLP) - Undistracted [ Time Frame: Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose ]
    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.

  2. Standard Deviation of Lateral Position (SDLP) - Distracted [ Time Frame: Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose ]
    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.

  3. Blood Delta-9-THC [ Time Frame: At baseline, 20, 90, and 180 minutes ]
    THC concentration levels of Delta-9-THC in whole blood.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05276232


Contacts
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Contact: Rose A Schmitt, B.S. 319-335-4666 rose-potter@uiowa.edu
Contact: Timothy L Brown, Ph.D. 319-335-4785 timothy-l-brown@uiowa.edu

Locations
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United States, Iowa
National Advanced Driving Simulator Recruiting
Iowa City, Iowa, United States, 52242
Contact: Rose A Schmitt, B.S.    319-335-4666    rose-potter@uiowa.edu   
Contact: Timothy L Brown, Ph.D.    319-335-4785    timothy-l-brown@uiowa.edu   
Principal Investigator: Timothy L Brown, Ph.D.         
Sub-Investigator: Gary R Gaffney, M.D.         
Sponsors and Collaborators
ISBRG Corp
National Advanced Driving Simulator
Investigators
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Principal Investigator: Timothy L Brown, Ph.D. National Advanced Driving Simulator
More Information
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Responsible Party: ISBRG Corp
ClinicalTrials.gov Identifier: NCT05276232    
Other Study ID Numbers: 202108451
First Posted: March 11, 2022    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ISBRG Corp:
Driving under the influence
Cannabis impairment
SpotLight-THC
 Non-invasive detection
THC
ISBRG
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders