Detection of Cannabis Impairment With ISBRG's SpotLight-THC
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedFirst Posted
Study publicly available on registry
March 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedMarch 11, 2022
February 1, 2022
5 months
February 11, 2022
March 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Standard Deviation of Lateral Position (SDLP) - Undistracted
Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose
Standard Deviation of Lateral Position (SDLP) - Distracted
Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose
Blood Delta-9-THC
At baseline, 20, 90, and 180 minutes
Study Arms (2)
Baseline followed by 5-10% THC Validation
EXPERIMENTALBaseline followed by 5-10% THC Verification
EXPERIMENTALInterventions
Cannabis vapor is produced from 500mg, approximately 5-10% High dose bulk cannabis plant material, 30-37.5 mg THC
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ISBRG Corplead
- National Advanced Driving Simulatorcollaborator
Study Sites (1)
National Advanced Driving Simulator
Iowa City, Iowa, 52242, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy L Brown, Ph.D.
National Advanced Driving Simulator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2022
First Posted
March 11, 2022
Study Start
March 1, 2022
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
March 11, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share