Clinical trial NCT03191084: Examine the Feasibility of a Standardized Field Test for Marijuana Impairment: Laboratory Evaluations
Official title: Examine the Feasibility of a Standardized Field Test for Marijuana Impairment: Laboratory Evaluations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Marijuana Impairment
Keywords: marijuana
THC
cannabis
driving
impairment
intoxication
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Highway Traffic Safety Administration (NHTSA)
name: Hartford Hospital
name: Montana State University
name: Maastricht University
name: The Mind Research Network
name: National Institute on Drug Abuse (NIDA)
First posted: 2017-06-19
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.)

Detailed description: This responds to NHTSA's request with a proposal to increase our understanding of smoked cannabis' (CNB's) acute effects on 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. The project also will link an extensive literature on CNB's effects on laboratory cognitive tests to simulated driving performance for the first time, providing a crucial validation of CNB's neurofunctional effects identifying maximally relevant candidate measures for field sobriety tests. To this goal, the proposed study was based upon a careful and thorough review of the scientific literature describing CNB effects on cognitive test performance and driving, as well as current state-of-knowledge on the sensitivity of biological assays for identifying recent CNB use. The study will carefully characterize the persistence of CNB's acute effects on cognitive test performance and driving over a several-hour time span. This will allow us to identify the point at which any effects of CNB intoxication on cognitive tests and driving performance cannot be distinguished from normal, i.e., the first step towards establishing standards for legal and social policy. 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.

Participants

Eligibility criteria: Inclusion Criteria:

* Must have a current driver's license
* Have used marijuana before
* Right handed

Exclusion Criteria:

* Females who are pregnant or breast feeding
* Any serious medical, or neurological disorder
* Any psychiatric disorder
* No major head traumas

Primary outcomes:
measure: Marijuana induced performance changes on Cogstate 1-back/2-back task.
timeFrame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
measure: Marijuana induced performance changes on Cogstate Card Learning.
timeFrame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
measure: Marijuana induced performance changes on Cogstate Groton Maze Learning task.
timeFrame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
measure: Marijuana induced performance changes on Cogstate Social/Emotional Cognition task.
timeFrame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
measure: Marijuana induced performance changes on Alertmeter.
timeFrame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
measure: Marijuana induced performance changes on the Time Estimation Task.
timeFrame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
measure: Marijuana induced performance changes on the Stop Signal Reaction Time task.
timeFrame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
measure: Marijuana induced performance changes on the Critical Tracking Task.
timeFrame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
measure: Marijuana induced performance changes on the ANAM Pursuit Tracking Task.
timeFrame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
measure: Marijuana induced performance changes on the Finger to Nose Task.
timeFrame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
measure: Marijuana induced performance changes on the One Leg Stand Task.
timeFrame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
measure: Marijuana induced performance changes on the Line Walking/Months Backwards Task.
timeFrame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
measure: Marijuana induced performance changes on the Time Reproduction Task.
timeFrame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Secondary outcomes:
measure: Change in concentration of THC/metabolites in blood samples.
timeFrame: 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.
measure: Change in concentration of THC/metabolites in oral fluid tested using Draeger Drug Detection Kits.
timeFrame: 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.
measure: Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
timeFrame: 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.
measure: Change in performance on simulated driving Road Tracking Task.
timeFrame: Post drug administration at: 1 hour, 3 hours and 5 hours
measure: Change in performance on simulated driving Car Following Task.
timeFrame: Post drug administration at: 1 hour, 3 hours and 5 hours
measure: Change in performance on simulated driving Gap Acceptance Task.
timeFrame: Post drug administration at: 1 hour, 3 hours and 5 hours
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Olin Neuropsychiatry Research Center
state: Connecticut
Study officials:
References: