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Standardized Field Test for Marijuana Impairment II (NHTSA-II)

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ClinicalTrials.gov Identifier: NCT05115513
Recruitment Status : Recruiting
First Posted : November 10, 2021
Last Update Posted : September 21, 2022
Sponsor:
Collaborators:
National Highway Traffic Safety Administration (NHTSA)
Hartford Hospital
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Godfrey Pearlson, Yale University

Brief Summary:
This research responds to NHTSA's request with a proposal to increase our understanding of smoked cannabis' (CNB's) acute effects on driving-relevant cognition and simulated driving performance, the persistence of these deficits over the hours after use, and the influence of prior experience with CNB on these effects. This extension study will aim to further investigate marijuana impaired behavior, using a similar design to our previous NHTSA Examine the Feasibility of a Standardized Field Test for Marijuana Impairment and the prior NIDA Neuroscience of Marijuana-Impaired Driving award, that used similar techniques and measures to quantify marijuana impaired automobile driving. We will be utilizing tasks and assessments that were shown to be strong indicators for cognitive and driving impairment in our NHTSA study.

Condition or disease Intervention/treatment Phase
Marijuana Impairment Drug: Medium THC Drug: Placebo THC Phase 1

Detailed Description:

The proposed study was based upon a careful and thorough review of the scientific literature describing CNB effects on cognitive test performance and driving, as well as current state-of-knowledge on the sensitivity of biological assays for identifying recent CNB use. The study will carefully characterize the persistence of CNB's acute effects on cognitive test performance and driving over a several-hour time span. This will allow us to identify the point at which any effects of CNB intoxication driving-related cognitive tests, and driving performance cannot be distinguished from normal, i.e., the first step towards establishing standards for legal and social policy. The data obtained from simulated driving, cognitive tests, and biological assays of THC will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk.

This study will consist of 2 days (screening visit and dose visit). In a non-randomized, single blinded study, we will dose participants with placebo and high THC marijuana, about an hour apart, using paced inhalation through a vaporizer, an efficient means of delivering a standard THC dose. Participants will be told that the order they receive the doses will be random but they will always receive the placebo first, followed by the high dose. This will allow for standardization across all subjects and comparative values between placebo and drug. After inhaling the placebo dose, participants will be asked to complete one round of cognitive testing and a shortened version of the driving simulator (10 mins vs 30 mins). Approximately one hour post placebo dose, subjects will be administered high THC marijuana. Following this dosing, we will assess impairment through cognitive testing as well as a simulated driving test and neuropsychological tests. Samples of blood will also be collected at multiple time points throughout the study visits to be measured for THC concentration and its metabolites. This allows clarification between the relationship of impairment, as well as subjective and objective intoxication, and levels of THC and it's metabolites in the users system.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Examine the Feasibility of a Standardized Field Test for Marijuana Impairment: Laboratory Evaluations II
Actual Study Start Date : August 25, 2022
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Placebo Marijuana
Placebo Marijuana will be administered.
Drug: Placebo THC
Marijuana flower with no THC

Experimental: Medium THC Marijuana
Medium THC marijuana will be administered.
Drug: Medium THC
Marijuana flower with medium THC




Primary Outcome Measures :
  1. Marijuana induced performance changes on Cogstate Groton Maze Learning task. [ Time Frame: Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes. ]
    The Cogstate Groton Maze Learning task assesses spatial learning and memory, it will be administered prior to dosing and at various time points after dosing.

  2. Marijuana induced performance changes on Inquisit Maze Learning task. [ Time Frame: Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes. ]
    The Inquisit Maze Learning task assesses spatial learning and memory, it will be administered prior to dosing and at various time points after dosing.

  3. Marijuana induced performance changes on the Time Reproduction Task. [ Time Frame: Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes. ]
    The Time Reproduction Task assesses general motor coordination plus timing, it will be administered prior to dosing and at various time points after dosing.


Secondary Outcome Measures :
  1. Change in concentration of THC/metabolites in blood samples. [ Time Frame: Post placebo at 5 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes. ]
    Blood samples with be collected at 5 times throughout each day to assess for changes of THC and its metabolite levels.

  2. Change in performance on simulated driving Road Tracking Task. [ Time Frame: Post placebo at 10 minutes and post active dose administration at 210 minutes. ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-55 yrs/ old
  • Current driver's license and history of repeated highway vehicle driving experience (at least 2 years)
  • Recent, recurrent CNB use and felt high when used
  • Able to read, speak, and understand English
  • Able and willing to provide written informed consent, and willing to commit to the study protocol

Exclusion Criteria:

  • Current marijuana tolerance, desire to cut down, or cravings to use during periods of abstinence
  • New CNB users who have not used at least once during their lifetime.
  • Positive screen for drug and alcohol (except THC) on test day will result in rescheduling the appointment
  • Former CNB users who are abstaining
  • Pregnancy, breastfeeding, and ineffective birth control methods.
  • History of adverse psychological or medical effects following cannabis use
  • serious medical, neuro-ophthalmological, or neurological illness (i.e. cancer, seizure disorders, encephalopathy)
  • History of head trauma with loss of consciousness > 30 minutes or concussion lasting 30 days.
  • IQ <80 on the Wechsler Abbreviated Scale of Intelligence
  • Inability to comprehend written instructions using the WRAT 4 reading achievement test
  • Any medical/neurological condition that could compromise neurocognitive performance (i.e. epilepsy, multiple sclerosis, fetal alcohol syndrome)
  • Uncontrolled, persistent high blood pressure
  • Anyone deemed unsafe to study personnel for any reason

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): NCT05115513


Contacts
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Contact: Suyash Adhikari, B.S 860-545-7106 Suyash.Adhikari@hhchealth.org
Contact: Diana King, B.A 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: Diana King, B.A    860-545-7563    Diana.King@hhchealth.org   
Principal Investigator: Godfrey Pearlson, MD/PhD         
Sponsors and Collaborators
Yale University
National Highway Traffic Safety Administration (NHTSA)
Hartford Hospital
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Godfrey Pearlson, M.D Yale University
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Responsible Party: Godfrey Pearlson, Professor of Psychiatry and Neuroscience, Founding Director Olin Neuropsychiatry Research Center, Yale University
ClinicalTrials.gov Identifier: NCT05115513    
Other Study ID Numbers: HHC-2021-0333
DTNH2216C00022 ( Other Identifier: Department of Transportation )
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Godfrey Pearlson, Yale University:
Marijuana
THC
Cannabis
Driving
Impairment
Intoxication
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists