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Neuroscience of Marijuana Impaired Driving (MJDriving)

Primary Purpose

Marijuana Impairment

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Low dose THC marijuana
High dose THC marijuana
Placebo marijuana
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Marijuana Impairment focused on measuring marijuana, driving, THC, cannabis, intoxication, MRI

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Olin Neuropsychiatry Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Regular Users

Occasional Users

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in performance on fMRI simulated driving Gap Acceptance Task
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.
Change in performance on fMRI simulated driving Road Tracking Task.
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.
Change in performance on fMRI simulated driving Car Following Task.
The Car Following Task measures tactical control of the vehicle. Tactical control of the vehicle is measured by following distance from a lead vehicle.
Change in concentration of THC/metabolites in oral fluid tested using Draeger Drug Detection Kits
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.
Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
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.
Change in concentration of THC/metabolites in blood samples.
Blood samples will be taken at 8 total time points throughout the day to assess for changes in concentration of THC and its metabolites.
Marijuana performance changes on the Critical Tracking Task.
The Critical Tracking Task assesses visuomotor tracking, it will be administered prior to dosing and at various time points after dosing.
Marijuana performance changes on the Tower of London task.
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.
Marijuana performance changes on the 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.
Marijuana performance changes on the Cogstate Detection Task.
The Cogstate Detection Task assesses processing speed, it will be administered prior to dosing and at various time points after dosing.
Marijuana performance changes on the Cogstate Set Shifting Task.
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

Change in performance on fMRI Set-Shifting paradigm.
The set shifting paradigm measures attentional and executive domains.
Change in performance on fMRI Time Estimation paradigm.
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.

Full Information

First Posted
April 11, 2016
Last Updated
June 30, 2022
Sponsor
Yale University
Collaborators
Hartford Hospital, National Institute on Drug Abuse (NIDA), Montana State University, Maastricht University, The Mind Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT02757313
Brief Title
Neuroscience of Marijuana Impaired Driving
Acronym
MJDriving
Official Title
Neuroscience of Marijuana Impaired Driving
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
Hartford Hospital, National Institute on Drug Abuse (NIDA), Montana State University, Maastricht University, The Mind Research Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Impairment
Keywords
marijuana, driving, THC, cannabis, intoxication, MRI

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regular Users
Arm Type
Experimental
Arm Description
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.
Arm Title
Occasional Users
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Low dose THC marijuana
Other Intervention Name(s)
THC, cannabis
Intervention Type
Drug
Intervention Name(s)
High dose THC marijuana
Other Intervention Name(s)
THC, cannabis
Intervention Type
Drug
Intervention Name(s)
Placebo marijuana
Other Intervention Name(s)
THC, cannabis
Primary Outcome Measure Information:
Title
Change in performance on fMRI simulated driving Gap Acceptance Task
Description
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.
Time Frame
Post drug administration at: 30 min, 3 hours and 5.25 hours
Title
Change in performance on fMRI simulated driving Road Tracking Task.
Description
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.
Time Frame
Post drug administration at: 30 min, 3 hours and 5.25 hours
Title
Change in performance on fMRI simulated driving Car Following Task.
Description
The Car Following Task measures tactical control of the vehicle. Tactical control of the vehicle is measured by following distance from a lead vehicle.
Time Frame
Post drug administration at: 30 min, 3 hours and 5.25 hours
Title
Change in concentration of THC/metabolites in oral fluid tested using Draeger Drug Detection Kits
Description
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.
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,
Title
Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
Description
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.
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,
Title
Change in concentration of THC/metabolites in blood samples.
Description
Blood samples will be taken at 8 total time points throughout the day to assess for changes in concentration of THC and its metabolites.
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,
Title
Marijuana performance changes on the Critical Tracking Task.
Description
The Critical Tracking Task assesses visuomotor tracking, it will be administered prior to dosing and at various time points after dosing.
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
Title
Marijuana performance changes on the Tower of London task.
Description
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.
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
Title
Marijuana performance changes on the Cogstate 1-back/2-back task.
Description
The Cogstate 1-back/2-back task assesses working memory, it will be administered prior to dosing and at various time points after dosing.
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
Title
Marijuana performance changes on the Cogstate Detection Task.
Description
The Cogstate Detection Task assesses processing speed, it will be administered prior to dosing and at various time points after dosing.
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
Title
Marijuana performance changes on the Cogstate Set Shifting Task.
Description
The Cogstate Set Shifting Task assesses executive functioning, it will be administered prior to dosing and at various time points after dosing.
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
Secondary Outcome Measure Information:
Title
Change in performance on fMRI Set-Shifting paradigm.
Description
The set shifting paradigm measures attentional and executive domains.
Time Frame
Post drug administration at: 1.25 hours, 3.5 hours and 6 hours
Title
Change in performance on fMRI Time Estimation paradigm.
Description
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.
Time Frame
Post drug administration at: 1.25 hours, 3.5 hours and 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Godfrey Pearlson
Organizational Affiliation
Founding Director Olin Research Center; Professor Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Olin Neuropsychiatry Research Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Neuroscience of Marijuana Impaired Driving

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