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Neuroscience of Marijuana Impaired Driving (MJDriving)

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ClinicalTrials.gov Identifier: NCT02757313
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : February 5, 2018
Sponsor:
Collaborators:
Hartford Hospital
National Institute on Drug Abuse (NIDA)
Montana State University
Maastricht University
The Mind Research Network
Information provided by (Responsible Party):
Godfrey Pearlson, Yale University

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.

Condition or disease Intervention/treatment Phase
Marijuana Impairment Drug: Low dose THC marijuana Drug: High dose THC marijuana Drug: Placebo marijuana Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Neuroscience of Marijuana Impaired Driving
Study Start Date : October 2016
Estimated Primary Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Regular Users
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.
Drug: Low dose THC marijuana
Other Name: THC, cannabis

Drug: High dose THC marijuana
Other Name: THC, cannabis

Drug: Placebo marijuana
Other Name: THC, cannabis

Experimental: Occasional Users
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.
Drug: Low dose THC marijuana
Other Name: THC, cannabis

Drug: High dose THC marijuana
Other Name: THC, cannabis

Drug: Placebo marijuana
Other Name: THC, cannabis




Primary Outcome Measures :
  1. Change in performance on fMRI simulated driving Gap Acceptance Task [ Time Frame: Post drug administration at: 30 min, 3 hours and 5.25 hours ]
    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.

  2. Change in performance on fMRI simulated driving Road Tracking Task. [ Time Frame: Post drug administration at: 30 min, 3 hours and 5.25 hours ]
    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.

  3. Change in performance on fMRI simulated driving Car Following Task. [ Time Frame: Post drug administration at: 30 min, 3 hours and 5.25 hours ]
    The Car Following Task measures tactical control of the vehicle. Tactical control of the vehicle is measured by following distance from a lead vehicle.

  4. Change in concentration of THC/metabolites in oral fluid tested using Draeger Drug Detection Kits [ Time Frame: 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, ]
    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.

  5. Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices. [ Time Frame: 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, ]
    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.

  6. Change in concentration of THC/metabolites in blood samples. [ Time Frame: 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, ]
    Blood samples will be taken at 8 total time points throughout the day to assess for changes in concentration of THC and its metabolites.

  7. Marijuana performance changes on the Critical Tracking Task. [ Time Frame: 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 ]
    The Critical Tracking Task assesses visuomotor tracking, it will be administered prior to dosing and at various time points after dosing.

  8. Marijuana performance changes on the Tower of London task. [ Time Frame: 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 ]
    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.

  9. Marijuana performance changes on the Cogstate 1-back/2-back task. [ Time Frame: 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 ]
    The Cogstate 1-back/2-back task assesses working memory, it will be administered prior to dosing and at various time points after dosing.

  10. Marijuana performance changes on the Cogstate Detection Task. [ Time Frame: 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 ]
    The Cogstate Detection Task assesses processing speed, it will be administered prior to dosing and at various time points after dosing.

  11. Marijuana performance changes on the Cogstate Set Shifting Task. [ Time Frame: 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 ]
    The Cogstate Set Shifting Task assesses executive functioning, it will be administered prior to dosing and at various time points after dosing.


Secondary Outcome Measures :
  1. Change in performance on fMRI Set-Shifting paradigm. [ Time Frame: Post drug administration at: 1.25 hours, 3.5 hours and 6 hours ]
    The set shifting paradigm measures attentional and executive domains.

  2. Change in performance on fMRI Time Estimation paradigm. [ Time Frame: Post drug administration at: 1.25 hours, 3.5 hours and 6 hours ]
    The time estimation paradigm measures misjudgment of time intervals based on participant responses indicating whether one time interval was the same, longer or shorter than the previous time interval.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757313


Contacts
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Contact: Catherine Boyle 860-545-7548 catherine.boyle@hhchealth.org
Contact: Diana King 860-545-7563 diana.king@hhchealth.org

Locations
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United States, Connecticut
Olin Neuropsychiatry Research Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Catherine Boyle, BS    860-545-7548    catherine.boyle@hhchealth.org   
Contact: Diana King, BA    860-545-7563    diana.king@hhchealth.org   
Sponsors and Collaborators
Yale University
Hartford Hospital
National Institute on Drug Abuse (NIDA)
Montana State University
Maastricht University
The Mind Research Network
Investigators
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Principal Investigator: Godfrey Pearlson Founding Director Olin Research Center; Professor Yale University

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Responsible Party: Godfrey Pearlson, Founding Director Olin Neuropsychiatry Research Center; Professor Yale University, Yale University
ClinicalTrials.gov Identifier: NCT02757313     History of Changes
Other Study ID Numbers: HHC-2015-0126
1R01DA038807-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Godfrey Pearlson, Yale University:
marijuana
driving
THC
cannabis
intoxication
MRI

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders