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:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT04230460
Eligibility Criteria:
Inclusion Criteria:
* Men and women 18 to 50 years of age in good health (21 to 50 for alcohol arm)
* Valid US driver's license and have been licensed driver for two years
* Restrictions on driver's license limited to vision correction only
* Drive at least three times per week
* Must be able to drive without special or non-standard equipment
* Must be able to attend three morning daytime study visits lasting approximately 5 to 6 hours
* Must be willing to abstain from alcohol use in the day prior to their study appointments
* Must be willing to abstain from use of their own cannabis while enrolled in the study
* Live within 1-hour driving radius of National Advanced Driving Simulator (NADS)
* Must currently use cannabis at least once every three months and no more than four times per week (must be current user)
* Peripheral veins suitable for venipuncture
* Blood pressure within clinically normal range
* If invited to complete alcohol arm: Must be considered a light or moderate drinker according to Quantity-Frequency-Variability Scale (QFV) or, if a heavy drinker, not drink more than 1-2 times a week and not have a modal quantity of 5-6 drinks
Exclusion Criteria:
* Females who are pregnant or test positive for pregnancy or are breastfeeding
* Any known sleep disorders, or family history of sleep disorders
* Any neurological or pulmonary disorders (or taking medications for such)
* Any psychiatric disorder (or taking medications for such)
* Any eating disorders
* Recent (past 5 years) head injury, or older head injury with current symptoms
* High blood pressure, Heart disease, diabetes, or history of stroke or taking medications to treat
* Any known behavioral or attention disorder (or taking medications for such)
* Untreated/Untreatable vision or auditory issues (because testing currently requires both senses)
* Excessive tobacco use (more than 10 cigarettes a day)
* Excessive caffeine use (5 or more servings per day)
* Excessive alcohol (20 or more drinks per week)
* Donation of 450 mL or more of blood in the two weeks preceding study drug administration
* Regular use of pain medications other than over-the-counter
* Any medication use that causes drowsiness or is contraindicated for driving
* Use of prescription drugs not prescribed to them or illicit drugs other than cannabis
* Propensity to motion sickness (more than 2-3 episodes where intensity is moderate or above)
* History of substance abuse or substance addiction
* Currently participating in or interested in drug abuse treatment, or participation in a program in past 60 days
* Current cannabis use disorder or alcohol use disorder \[as determined by scores on the Cannabis Use Disorder Identification Test (CUDIT) and Alcohol Use Disorder Identification Test (AUDIT)\]
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04230460
Study Brief:
Protocol Section:
NCT04230460