NCT02757313|CompletedPhase 1DMC
Neuroscience of Marijuana Impaired Driving
MJDriving
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MJDriving
Sponsor study identifier
Secondary identifiers
interventional
62
1 country
1
Study Start
October 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2021
Actual (reported)Study Completion
May 2021
Actual (reported)Marijuana is one of the most widely used substances. However, marijuana intoxication is not fully understood in relation to driving. This study will help the investigators learn more about the potential impairments related to marijuana intoxicated driving. A combination of MRI and neuropsychological tests (which are computer and paper/pencil tasks) will be used to measure intoxication and impairment. This study will also assess levels of marijuana in blood and saliva samples. This study takes place in Hartford, Connecticut.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2021
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 11, 2016
Actual (reported)May 2, 2016
Actual (reported)October 2016
Date type not reportedThis date has not been verified as actual or estimated.
May 2021
Actual (reported)May 2021
Actual (reported)Change in performance on fMRI simulated driving Gap Acceptance Task
The Gap Acceptance Task measures strategic control of the vehicle. Strategic control of the vehicle is measured by size of headway gaps that the participant chooses in pulling out into a stream of traffic.
Post drug administration at: 30 min, 3 hours and 5.25 hours
Change in performance on fMRI simulated driving Road Tracking Task.
The Road Tracking Task measures operational control of the vehicle. Operational control is measured by standard deviation of lane position from the center point of the lane.
Post drug administration at: 30 min, 3 hours and 5.25 hours
Change in performance on fMRI simulated driving Car Following Task.
The Car Following Task measures tactical control of the vehicle. Tactical control of the vehicle is measured by following distance from a lead vehicle.
Post drug administration at: 30 min, 3 hours and 5.25 hours
Change in concentration of THC/metabolites in oral fluid tested using Draeger Drug Detection Kits
Saliva samples will be taken at 8 total time points throughout the day using the Draeger Drug Detection kits to assess for changes in concentration of THC and its metabolites.
Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min,
Change in performance on fMRI Set-Shifting paradigm.
Post drug administration at: 1.25 hours, 3.5 hours and 6 hours
Change in performance on fMRI Time Estimation paradigm.
Post drug administration at: 1.25 hours, 3.5 hours and 6 hours
People who use marijuana regularly will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the study visits.
People who use marijuana occasionally will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the study visits.
Olin Neuropsychiatry Research Center
Hartford, Connecticut, 06106, United States
Godfrey Pearlson
Founding Director Olin Research Center; Professor Yale University
62 participants (actual enrollment reported by the registry).
First Submitted
April 11, 2016
First Posted
May 2, 2016
Study Start
October 2016
Date type not reportedChange in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
Saliva samples will be taken at 8 total time points throughout the day using the Quantisal Oral Fluid Collection devices to assess for changes in concentration of THC and its metabolites.
Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min,
Change in concentration of THC/metabolites in blood samples.
Blood samples will be taken at 8 total time points throughout the day to assess for changes in concentration of THC and its metabolites.
Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min,
Marijuana performance changes on the Critical Tracking Task.
The Critical Tracking Task assesses visuomotor tracking, it will be administered prior to dosing and at various time points after dosing.
Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
Marijuana performance changes on the Tower of London task.
The Tower of London is a task that assesses executive functioning, it will be administered prior to dosing and at various time points after dosing.
Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
Marijuana performance changes on the 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.
Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
Marijuana performance changes on the Cogstate Detection Task.
The Cogstate Detection Task assesses processing speed, it will be administered prior to dosing and at various time points after dosing.
Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
Marijuana performance changes on the Cogstate Set Shifting Task.
The Cogstate Set Shifting Task assesses executive functioning, it will be administered prior to dosing and at various time points after dosing.
Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
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.
This date has not been verified as actual or estimated.
Primary Completion
May 2021
Actual (reported)Study Completion
May 2021
Actual (reported)Last Updated
July 23, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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