Status:
UNKNOWN
Detection of Cannabis Impairment With ISBRG's SpotLight-THC
Lead Sponsor:
ISBRG Corp
Collaborating Sponsors:
National Advanced Driving Simulator
Conditions:
Cannabis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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. Subje...
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 phys...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05276232
Start Date
March 1 2022
End Date
August 1 2022
Last Update
March 11 2022
Active Locations (1)
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1
National Advanced Driving Simulator
Iowa City, Iowa, United States, 52242