NCT04856566|CompletedEarly Phase 1DMCFDA Drug
Examine the Feasibility of a Standardized Field Test for Marijuana and Alcohol Impairment: Laboratory Evaluations
Alc-NHTSA
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Sponsor study identifier
Secondary identifiers
OTHER · Department of Transportation
interventional
41
1 country
1
Study Start
July 28, 2021
Actual (reported)Primary Completion
August 23, 2023
Actual (reported)Study Completion
August 23, 2023
Actual (reported)Alcohol and Cannabis (CNB) are two of the most widely used intoxicants. The effects of driving while intoxicated on alcohol are well documented, resulting in numerous drunken driving laws and regulations. As CNB begins to be decriminalized, medical CNB use allowed in multiple U.S. states, and perception of harmfulness falls, CNB use is predicted to rise and it will become increasingly common to publicly encounter persons who recently used the drug. An area of potentially high concern is if ever-greater numbers of CNB users and its legalization will increase the risk of driving while intoxicated from recent CNB use, thereby increasing the risks to public safety. This study aims to examine the combined effects of smoking marijuana and drinking alcohol on simulated driving.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 23, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 19, 2021
Actual (reported)April 23, 2021
Actual (reported)July 28, 2021
Actual (reported)August 23, 2023
Actual (reported)August 23, 2023
Actual (reported)Marijuana and alcohol induced performance changes on Cogstate 1-back/2-back task.
The Cogstate 1-back/2-back task assesses working memory, it will be administered prior to dosing and at various time points after dosing.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Cogstate Social/Emotional Cognition Task.
The Cogstate Social/Emotional Cognition task assesses emotional processing, it will be administered prior to dosing and at various time points after dosing.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on Cogstate Card Learning.
The Cogstate Card Learning task assesses visual memory, it will be administered prior to dosing and at various time points after dosing.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Change in concentration of THC/metabolites in blood samples.
Baseline and post drug administration at: 30 min; 2.5 hours
Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
Baseline and post drug administration at: 30 min; 2.5 hours
Change in performance on simulated driving Road Tracking Task.
Post drug administration at: 30 min; 2.5 hours, 5 hours
Change in performance on simulated driving Car Following Task.
Post drug administration at: 30 min; 2.5 hours, 5 hours
Change in performance on simulated driving Gap Acceptance Task.
Post drug administration at: 30 min; 2.5 hours, 5 hours
Participants will receive low dose of THC along with alcohol leading to a BAC of 0.05.
Participants will receive high dose of THC along with alcohol leading to a BAC of 0.05.
Cannabis with low amount of THC
Cannabis with high amount of THC
Hartford Hospital
Hartford, Connecticut, 06106, United States
Godfrey Pearlson, M.D
Founding Director, Olin Neuropsychiatry Center; Yale University
41 participants (actual enrollment reported by the registry).
First Submitted
April 19, 2021
First Posted
April 23, 2021
Study Start
July 28, 2021
Actual (reported)Alcohol Impairment Detection in Healthy Adult Users With the Gaize Device
Marijuana and alcohol induced performance changes on Groton Maze Learning task.
The Cogstate Groton Maze Learning task assesses spatial learning and memory, it will be administered prior to dosing and at various time points after dosing.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on Alertmeter.
The Alertmeter task assess visual judgment and alertness, it will be administered prior to dosing and at various time points after dosing.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Time Estimation task.
The Time Estimation Task assesses timing, it will be administered prior to dosing and at various time points after dosing.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Go-No-Go task.
The Go-No-Go task assesses inhibitory processing, it will be administered prior to dosing and at various time points after dosing.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Ramaeker's Critical Tracking Test.
The Raemaker's Critical Tracking Test assesses hand eye coordination and visuomotor tracking, it will be administered prior to dosing and at various time points after dosing.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the ANAM Pursuit Tracking Task.
The ANAM Pursuit Tracking Task assesses hand eye coordination, it will be administered prior to dosing and at various time points after dosing.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Finger to Nose Task.
The Finger to Nose Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the One Leg Stand Task.
The One Leg Stand Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Line Walking/Months Backwards Task.
The Line Walking/Months Backwards Task assesses general motor coordination plus distraction, it will be administered prior to dosing and at various time points after dosing.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Time Reproduction Task.
The Time Reproduction Task assesses general motor coordination plus timing, it will be administered prior to dosing and at various time points after dosing.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Ipod Balance Task.
Participants will have an elastic wrap around their hips with an Ipod attached via durable velco. They will be asked to stand with both feet flat on the ground, looking ahead at a fixed point on the wall for 30 seconds, as well as 30 seconds with eyes closed. The amount of body sway will be measured using the accelerometer in an Ipod.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Ipod Punching Task.
Participants will have an elastic wrap around their forearm with an Ipod attached via durable velrco. They will be asking to punch their arm forward while seated in a chair to measure their peak velocity of punching through the accelerometer in the Ipod.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the DRUID tasks.
DRUID is an application that has been designed to measure cognitive and behavior impairment following ingestion of drugs such as alcohol or marijuana. DRUID includes four Tasks to measure performance. The tasks are based on research on driving impairment and take about 5 minutes to complete. These tasks include a Reaction Time/Decision Making/DAT in which the subject has to press in two different locations on the Ipod screen dependent on which target shape appeared. The second task is a Reaction Time/Time Estimation/DAT task in which the subjects has to internally count up to 60 seconds while also touching the screen each time a target shape appears on the screen. The third task is a Motor Tracking/DAT tasks in which the subject must keep their finger on a moving circle on the screen. The last task is a balance task in which the subject is told to stand on one foot with the Ipod in an opposite hand keeping it as still as possible.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Participants will receive placebo drug with no THC along with alcohol leading to a BAC of 0.05.
Participants will receive placebo drug with no THC along with alcohol leading to a BAC of 0.08.
Placebo drug with no THC
Amount of alcohol when consumed leads to BAC of 0.05
Amount of alcohol when consumed leads to BAC of 0.08
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 23, 2023
Actual (reported)Study Completion
August 23, 2023
Actual (reported)Last Updated
July 1, 2025
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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