Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT05276232
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05276232
Study Brief:
Protocol Section:
NCT05276232