NCT05115513|CompletedPhase 1DMCFDA Drug
Standardized Field Test for Marijuana Impairment II
NHTSA-II
Examine the Feasibility of a Standardized Field Test for Marijuana Impairment: Laboratory Evaluations II
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Sponsor study identifier
Secondary identifiers
OTHER · Department of Transportation
OTHER · Yale IRB
interventional
41
1 country
1
Study Start
August 25, 2022
Actual (reported)Primary Completion
August 21, 2023
Actual (reported)Study Completion
August 21, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 21, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 29, 2021
Actual (reported)November 10, 2021
Actual (reported)August 25, 2022
Actual (reported)August 21, 2023
Actual (reported)August 21, 2023
Actual (reported)Marijuana induced performance changes on Cogstate 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.
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.
The Inquisit Maze Learning task assesses spatial learning and memory, it will be administered prior to dosing and at various time points after dosing.
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.
The Time Reproduction Task assesses general motor coordination plus timing, it will be administered prior to dosing and at various time points after dosing.
Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.
Change in concentration of THC/metabolites in blood samples.
Post placebo at 5 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.
Change in performance on simulated driving Road Tracking Task.
Post placebo at 10 minutes and post active dose administration at 210 minutes.
Placebo Marijuana will be administered.
Medium THC marijuana will be administered.
Olin Neuropsychiatry Research Center
Hartford, Connecticut, 06106, United States
Godfrey Pearlson, M.D
Yale University
41 participants (actual enrollment reported by the registry).
First Submitted
October 29, 2021
First Posted
November 10, 2021
Study Start
August 25, 2022
Actual (reported)Cannabinoid Receptor Function & Alcoholism
Contact the study team to confirm eligibility.
Primary Completion
August 21, 2023
Actual (reported)Study Completion
August 21, 2023
Actual (reported)Last Updated
October 9, 2025
Record last verified: 2025-10
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Source: ClinicalTrials.gov.
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