Neuroscience of Marijuana Impaired Driving (MJDriving)

June 30, 2022 updated by: Godfrey Pearlson, Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Olin Neuropsychiatry Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • THC, cannabis
Drug: High dose THC marijuana
Other Names:
  • THC, cannabis
Drug: Placebo marijuana
Other Names:
  • 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 Names:
  • THC, cannabis
Drug: High dose THC marijuana
Other Names:
  • THC, cannabis
Drug: Placebo marijuana
Other Names:
  • THC, cannabis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post drug administration at: 30 min, 3 hours and 5.25 hours
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.
Post drug administration at: 30 min, 3 hours and 5.25 hours
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.
Post drug administration at: 30 min, 3 hours and 5.25 hours
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.
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.
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.
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 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.
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,
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.
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
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.
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
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.
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
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.
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
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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.
Post drug administration at: 1.25 hours, 3.5 hours and 6 hours
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.
Post drug administration at: 1.25 hours, 3.5 hours and 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)
Hartford Hospital
Maastricht University
Montana State University
The Mind Research Network

Investigators

  • Principal Investigator: Godfrey Pearlson, Founding Director Olin Research Center; Professor Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1507016175
  • 1R01DA038807-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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