CompletedNot Applicable

Cannabis Impairment Detection Application (CIDA)

United States124 participantsStarted 2020-09-01

Plain-language summary

Subjects will participate in a 4-visit study protocol in which they will be asked to complete a set of computerized tasks and a 45-minute simulated drive in a driving simulator. Subjects will be administered marijuana of varying pre-determined concentrations of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) during 3 of the visits and alcohol during one of the visits. Throughout the duration of each visit, brain activity will be measured noninvasively using an electroencephalogram (EEG) headset. The purpose of this study is to: 1. Further understand the effects of acute cannabis intoxication on driving performance in a driving simulator 2. Develop and refine brain-based biomarkers of impairment due to acute cannabis intoxication

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 (p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Driving Performance

Timeframe: Through entire 45-minute drive, 0.5-1.3 hour post cannabis administration

EEG Measures

Timeframe: Between -0.7 hours and 8 hours post cannabis administration

ECG Measures

Timeframe: Between -0.7 hours and 8 hours post cannabis administration

Trial details

NCT IDNCT04230460

SponsorAdvanced Brain Monitoring, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-27

View on ClinicalTrials.gov More Driving Under the Influence trials