Neuroscience of Marijuana Impaired Driving (MJDriving)

July 22, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Hartford Hospital
Maastricht University
Montana State University
The Mind Research Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1507016175
  • 1R01DA038807-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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