Clinical trial NCT02757313: Neuroscience of Marijuana Impaired Driving
Official title: Neuroscience of Marijuana Impaired Driving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Marijuana Impairment
Keywords: marijuana
driving
THC
cannabis
intoxication
MRI
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Hartford Hospital
name: National Institute on Drug Abuse (NIDA)
name: Montana State University
name: Maastricht University
name: The Mind Research Network
First posted: 2016-05-02
Enrollment: 62
Sex: ALL
Minimum age (years): 18
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. 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.

Detailed description: Cannabis is a commonly abused drug whose use cuts across social class, is linked to cognitive impairment, and may be a major contributor to intoxication-related accidents - either alone or with alcohol. However, cannabis intoxication is little studied in relation to driving compared to alcohol. Not only does the current NHTSA Strategic Plan for Behavioral Research prioritize understanding how drugs other than alcohol contribute to traffic crashes, it has recently become more pressing to understand the effects of cannabis because of increasing rates of legalized medical and/or recreational use, that will likely result in more cannabis intoxicated drivers. Social and legal policy will be unable to effectively address the many concerns about driving safety raised by more frequent and widespread use of cannabis without new research to better determine the parameters within which cannabis use does, or does not, increase automobile accident risk. The purpose of this study is to better describe specific, driving-related cognitive impairments caused by acute cannabis intoxication, their persistence over time, underlying functional brain anatomy, and relationship to performance on a state-of the art validated simulated driving task in which the investigators have prior experience. In a randomized, counterbalanced, double-blinded fashion, the investigators will administer two cannabis doses and placebo of smoked cannabis (paced inhalation using a vaporizer) to 48 regular cannabis users and 48 occasional cannabis users on 3 separate occasions. Following cannabis dosing cognitive and driving impairment will be assessed longitudinally for several hours using a combination of fMRI and neuropsychological tests, to clarify relationships between subjective and objective measures of intoxication and of impairment, that include expert assessment of THC and its metabolite levels in blood and saliva. This study takes place in Hartford, Connecticut.

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
* Unable or unsafe to have an MRI
* Any serious medical, or neurological disorder
* Any psychiatric disorder
* No major head traumas

Primary outcomes:
measure: Change in performance on fMRI simulated driving Gap Acceptance Task
timeFrame: Post drug administration at: 30 min, 3 hours and 5.25 hours
measure: Change in performance on fMRI simulated driving Road Tracking Task.
timeFrame: Post drug administration at: 30 min, 3 hours and 5.25 hours
measure: Change in performance on fMRI simulated driving Car Following Task.
timeFrame: Post drug administration at: 30 min, 3 hours and 5.25 hours
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 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: Marijuana performance changes on the Critical Tracking Task.
timeFrame: 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
measure: Marijuana performance changes on the Tower of London task.
timeFrame: 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
measure: Marijuana performance changes on the Cogstate 1-back/2-back task.
timeFrame: 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
measure: Marijuana performance changes on the Cogstate Detection Task.
timeFrame: 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
measure: Marijuana performance changes on the Cogstate Set Shifting Task.
timeFrame: 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
Secondary outcomes:
measure: Change in performance on fMRI Set-Shifting paradigm.
timeFrame: Post drug administration at: 1.25 hours, 3.5 hours and 6 hours
measure: Change in performance on fMRI Time Estimation paradigm.
timeFrame: Post drug administration at: 1.25 hours, 3.5 hours and 6 hours
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Olin Neuropsychiatry Research Center
state: Connecticut
Study officials:
affiliation: Founding Director Olin Research Center; Professor Yale University
name: Godfrey Pearlson
role: PRINCIPAL_INVESTIGATOR
References: