NCT03191084|CompletedEarly Phase 1DMCFDA Drug
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Sponsor study identifier
Secondary identifiers
OTHER · Department of Transportation, (U.S.)
interventional
26
1 country
1
Study Start
December 1, 2017
Actual (reported)Primary Completion
March 30, 2020
Actual (reported)Study Completion
March 30, 2020
Actual (reported)Marijuana is one of the most widely used substances. This study will characterize the persistence of cannabis' (CNB's) acute effects on cognitive test performance and simulated driving over a several hour time period. The data obtained from simulated driving, cognitive tests, and biological assays of THC will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk. Eligible participants will undergo a full day screening visit, if still eligible they will come to Hartford Hospital in Hartford, Connecticut to take part in the full study. Participation requires overnight stays between each of the five study visits. On each of the study days participants are dosed with either a low dose of THC marijuana, a high dose of THC marijuana or placebo marijuana, (the low and high doses are repeated once each, order in which the study drug is given is double blind and chosen at random.)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2020
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.
June 15, 2017
Actual (reported)June 19, 2017
Actual (reported)December 1, 2017
Actual (reported)March 30, 2020
Actual (reported)March 30, 2020
Actual (reported)Marijuana 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; 4.5 hours; 6.5 hours
Marijuana 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; 4.5 hours; 6.5 hours
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.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Marijuana induced performance changes on 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; 4.5 hours; 6.5 hours
Change in concentration of THC/metabolites in blood samples.
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 oral fluid tested using Draeger Drug Detection Kits.
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 oral fluid tested using Quantisal Oral Fluid Collection devices.
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 simulated driving Road Tracking Task.
Post drug administration at: 1 hour, 3 hours and 5 hours
Change in performance on simulated driving Car Following Task.
Post drug administration at: 1 hour, 3 hours and 5 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 five 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 five study visits.
Dosing via vaporized marijuana using a lower concentration of THC, participants receive this dose on two of the five study visits.
Dosing via vaporized marijuana using a higher concentration of THC, participants receive this dose on two of the five study visits.
Olin Neuropsychiatry Research Center
Hartford, Connecticut, 06106, United States
26 participants (actual enrollment reported by the registry).
First Submitted
June 15, 2017
First Posted
June 19, 2017
Study Start
December 1, 2017
Actual (reported)Marijuana 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; 4.5 hours; 6.5 hours
Marijuana 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; 4.5 hours; 6.5 hours
Marijuana induced performance changes on the Stop Signal Reaction Time task.
The Stop Signal Reaction Time 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; 4.5 hours; 6.5 hours
Marijuana induced performance changes on the Critical Tracking Task.
The Critical Tracking Task 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; 4.5 hours; 6.5 hours
Marijuana 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; 4.5 hours; 6.5 hours
Marijuana 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; 4.5 hours; 6.5 hours
Marijuana 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; 4.5 hours; 6.5 hours
Marijuana 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; 4.5 hours; 6.5 hours
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.
Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Dosing via vaporized marijuana with no THC, participants receive this dose on one of the five study visits.
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
March 30, 2020
Actual (reported)Study Completion
March 30, 2020
Actual (reported)Last Updated
July 23, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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