CompletedPhase 1

Standardized Field Test for Marijuana Impairment II

United States41 participantsStarted 2022-08-25

Plain-language summary

This research responds to NHTSA's request with a proposal to increase our understanding of smoked cannabis' (CNB's) acute effects on driving-relevant cognition and simulated driving performance, the persistence of these deficits over the hours after use, and the influence of prior experience with CNB on these effects. This extension study will aim to further investigate marijuana impaired behavior, using a similar design to our previous NHTSA Examine the Feasibility of a Standardized Field Test for Marijuana Impairment and the prior NIDA Neuroscience of Marijuana-Impaired Driving award, that used similar techniques and measures to quantify marijuana impaired automobile driving. We will be utilizing tasks and assessments that were shown to be strong indicators for cognitive and driving impairment in our NHTSA study.

Who can participate

Age range

18 Years – 55 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: * 18-55 yrs/ old * Current driver's license and history of repeated highway vehicle driving experience (at least 2 years) * Recent, recurrent CNB use and felt high when used * Able to read, speak, and understand English * Able and willing to provide written informed consent, and willing to commit to the study protocol Exclusion Criteria: * Current marijuana tolerance, desire to cut down, or cravings to use during periods of abstinence * New CNB users who have not used at least once during their lifetime. * Positive screen for drug and alcohol (except THC) on test day will result in rescheduling the appointment * Former CNB users who are abstaining * Pregnancy, breastfeeding, and ineffective birth control methods. * History of adverse psychological or medical effects following cannabis use * serious medical, neuro-ophthalmological, or neurological illness (i.e. cancer, seizure disorders, encephalopathy) * History of head trauma with loss of consciousness \> 30 minutes or concussion lasting 30 days. * IQ \<80 on the Wechsler Abbreviated Scale of Intelligence * Inability to comprehend written instructions using the WRAT 4 reading achievement test * Any medical/neurological condition that could compromise neurocognitive performance (i.e. epilepsy, multiple sclerosis, fetal alcohol syndrome) * Uncontrolled, persistent high blood pressure * Anyone deemed unsafe to study personnel for any reason

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

Marijuana induced performance changes on Cogstate Groton Maze Learning task.

Timeframe: Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.

Marijuana induced performance changes on Inquisit Maze Learning task.

Timeframe: Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.

Marijuana induced performance changes on the Time Reproduction Task.

Timeframe: Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.

Trial details

NCT IDNCT05115513

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-21

View on ClinicalTrials.gov More Marijuana Impairment trials

Plain-language summary

Who can participate

Age range

18 Years – 55 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.

What they're measuring

Marijuana induced performance changes on Cogstate Groton Maze Learning task.

Timeframe: Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.

Marijuana induced performance changes on Inquisit Maze Learning task.

Timeframe: Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.

Marijuana induced performance changes on the Time Reproduction Task.

Timeframe: Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.