Neuroscience of Marijuana Impaired Driving

NCT02757313 | Completed Phase 1 DMC

• 2 other identifiers: 15070161751R01DA038807-01A1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Marijuana Impairment

Keywords

marijuana; driving; THC; cannabis; intoxication; MRI

Outcome Measures

Primary Outcomes (11)

• 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.

  Post drug administration at: 30 min, 3 hours and 5.25 hours

• 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.

  Post drug administration at: 30 min, 3 hours and 5.25 hours

• 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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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 Outcomes (2)

• Change in performance on fMRI Set-Shifting paradigm.

  Post drug administration at: 1.25 hours, 3.5 hours and 6 hours

• Change in performance on fMRI Time Estimation paradigm.

  Post drug administration at: 1.25 hours, 3.5 hours and 6 hours

Study Arms (2)

Regular Users

EXPERIMENTAL

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; Drug: High dose THC marijuana; Drug: Placebo marijuana

Occasional Users

EXPERIMENTAL

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; Drug: High dose THC marijuana; Drug: Placebo marijuana

Interventions

Low dose THC marijuana DRUG

Also known as: THC, cannabis

Occasional Users; Regular Users

High dose THC marijuana DRUG

Also known as: THC, cannabis

Occasional Users; Regular Users

Placebo marijuana DRUG

Also known as: THC, cannabis

Occasional Users; Regular Users

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must have a current driver's license
• Have used marijuana before
• Right handed

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Hartford Hospital: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Montana State University: collaborator
• Maastricht University: collaborator
• The Mind Research Network: collaborator

Study Sites (1)

Olin Neuropsychiatry Research Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol; nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Godfrey Pearlson

  Founding Director Olin Research Center; Professor Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founding Director Olin Neuropsychiatry Research Center; Professor Yale University

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: May 2, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)