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Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim (PDID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04970342
Recruitment Status : Completed
First Posted : July 21, 2021
Last Update Posted : August 26, 2021
Sponsor:
Collaborators:
National Highway Traffic Safety Administration (NHTSA)
Acclaro Research Solutions, Inc.
Cognitive Research Corporation
Information provided by (Responsible Party):
Timothy L. Brown, University of Iowa

Brief Summary:

Subjects will participate in a 4-visit study protocol at the National Advanced Driving Simulator, part of the University of Iowa, in which they will be asked to complete assorted questionnaires, computerized cognitive tasks, and a simulator drive. Subjects will be administered 0.75 mg alprazolam (Xanax) or placebo and 500 mg vaporized cannabis (6.18% THC / <0.025% CBD) or placebo (0% THC / 0% CBD).

The primary objective of this study is to validate the Drug Impaired Driving Scenario (DIDS) using the CRCDS-2 driving simulator by assessing the acute effects of cannabis relative to placebo on simulated driving performance. Assay sensitivity will be demonstrated by the significant effect of 0.75 mg alprazolam (active comparator) on driving and cognitive endpoints.


Condition or disease Intervention/treatment Phase
Driving Behavior Driving Under the Influence Drug: Placebo (Lactose) Capsule Drug: 0.75 mg Alprazolam Capsule Drug: Cannabis (6.18% THC / <0.025% CBD) Drug: Cannabis (0%/ THC / 0% CBD) Phase 1

Detailed Description:

At the University of Iowa's National Advanced Driving Simulator (NADS), normal healthy subjects who currently use cannabis recreationally (at least once a month) will be recruited. The study involves four visits, the first of which is a screening visit of approximately 3 hours. At the screening visit, consent is obtained, questionnaires are given, and a physical and psychological exam is administered. Subjects will also train on study procedures, such as the cognitive testing, the simulator drive, and the cannabis inhalation procedure. Subjects will then be scheduled for their three treatment visits, which will be one week apart..

The treatment visits will have a clean (double placebo) and two treatment visits (active alprazolam and placebo cannabis, placebo alprazolam and active cannabis). The alprazolam dose is 0.75 mg and the cannabis dose is 500 mg. All cannabis will be inhaled via a Volcano® Digit vaporizer using the Foltin Puff Procedure. Each of the treatment visits will last approximately twenty-three hours and will include intake with eligibility and baseline testing, transport to a local hotel, an overnight stay at the hotel, transport to NADS, being dosed with study drugs or placebos, cognitive assessments, a simulator drive, and assorted questionnaires. There will also be 8 mL blood sampling before dosing, before driving, and after driving.

Meals will be provided at the treatment visits (dinner, snack, breakfast, lunch). Subjects will be monitored until the drug effects have subsided sufficiently to ensure it is safe to transport them home. Subjects will need to arrange their own transportation; they will not be permitted to drive themselves home after the treatment visits.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study uses two treatments - alprazolam and cannabis - and placebo. Subjects are randomized to a study arm where the order of treatments is counter-balanced, but all treatments and placebo are received by all subjects. At a visit, you might receive placebo alprazolam and placebo cannabis, placebo alprazolam and active cannabis, or active alprazolam and placebo cannabis. There is not a visit where you receive both active alprazolam and active cannabis.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Study Site/National Advanced Driving Simulator: Triple (Participant, Investigator, Outcomes Assessor) blind
Primary Purpose: Basic Science
Official Title: Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim: Evaluating Sensitivity to the Effects of Cannabis and Alprazolam
Actual Study Start Date : July 16, 2021
Actual Primary Completion Date : August 21, 2021
Actual Study Completion Date : August 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Alprazolam

Arm Intervention/treatment
Experimental: "Sober" or Double Placebo
Subject receives alprazolam capsule containing placebo (lactose). Subject receives placebo cannabis (0% THC / 0% CBD).
Drug: Placebo (Lactose) Capsule
Single dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose
Other Names:
  • Placebo
  • Placebo Alprazolam

Drug: Cannabis (0%/ THC / 0% CBD)
Cannabis vapor is produced from 500 mg of dried plant material (0% THC / 0% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose at two of the three study visits.
Other Names:
  • Marijuana
  • Marihuana
  • Placebo Cannabis
  • Placebo

Experimental: Active Alprazolam (Xanax), Placebo Cannabis
Subject receives active 0.75 mg alprazolam capsule. Subject receives placebo cannabis (0% THC / 0% CBD).
Drug: 0.75 mg Alprazolam Capsule
Single dose on one of the three study visits, orally administered 40 minutes prior to cannabis dose
Other Names:
  • Xanax
  • Active Alprazolam
  • Active Xanax

Drug: Cannabis (0%/ THC / 0% CBD)
Cannabis vapor is produced from 500 mg of dried plant material (0% THC / 0% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose at two of the three study visits.
Other Names:
  • Marijuana
  • Marihuana
  • Placebo Cannabis
  • Placebo

Experimental: Placebo Alprazolam (Xanax), Active Cannabis
Subject receives alprazolam capsule containing placebo (lactose). Subject receives active cannabis (6.18% THC / <0.025% CBD).
Drug: Placebo (Lactose) Capsule
Single dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose
Other Names:
  • Placebo
  • Placebo Alprazolam

Drug: Cannabis (6.18% THC / <0.025% CBD)
Cannabis vapor is produced from 500 mg of dried plant material (6.18% THC / <0.025% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose on one of the three study visits.
Other Names:
  • Marijuana
  • Marihuana
  • Active Cannabis




Primary Outcome Measures :
  1. Standard Deviation of Lateral Position (SDLP) [ Time Frame: over one hour during the course of the simulator drive at each of the three treatment visits ]

Secondary Outcome Measures :
  1. Lane Exceedences [ Time Frame: over one hour during the course of the simulator drive at each of the three treatment visits ]
    Count of the number of times the simulated vehicle leaves the driving lane, will be compared across treatments

  2. Reaction Time [ Time Frame: approximately 10 minutes twice each treatment visit (total of six times) for total of approximately one hour ]
    From CogScreen Continuous Performance Test



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Understands and provides written informed consent prior to the initiation of any protocol-specific procedures.
  • Able to comprehend and willing to comply with the requirements of the protocol.
  • Healthy male or female adult, 19 to 45 years of age, inclusive, at Screening.
  • Regular sleep pattern (usual bedtime between 21:00 and 00:00).
  • Score <10 on Epworth Sleepiness Scale at Screening.
  • Able to reliably perform study assessments at Screening (SDLP no higher than 1 standard deviation greater than the mean for normal healthy adults completing the practice scenario; Single Digit Coding (SDC) Correct no less than 1 standard deviation below the mean for healthy adults in their age range); demonstrates the ability to understand task instructions at Screening; and is physically (e.g., adequate manual dexterity, vision, and hearing) and cognitively capable of performing study tasks at Screening.
  • Possesses (and is willing to provide) a valid driver's license and is an active driver (minimum of approximately 3,000 miles per year for the previous 3 years).
  • Either an infrequent user of cannabis (i.e., 1-10 uses per month) or a frequent user of cannabis (i.e., >20 uses per month) over the preceding 90 days.
  • Willing to abstain from cannabis use (other than study drug) beginning 7 days prior to admission for the first treatment period (Day 1) until discharge from the facility on Day 2 of period 3.
  • Female subjects must meet one of the following criteria: 1) If of childbearing potential, female subjects agree to use two contraceptive regimens or remain abstinent during the study; or 2) if of non-childbearing potential, female subjects should be surgically sterile or in a menopausal state.

Exclusion Criteria:

  • A significant history and/or presence of hepatic, renal, cardiovascular, pulmonary, neurological, psychiatric, gastrointestinal, hematological, immunologic, ophthalmologic, metabolic, or oncological disease, or any other medical issue that would, in the opinion of the Investigator, present undue risk for the subject in the study.
  • A history of suicidal behavior within 24 months of Screening, has answered YES to questions 3, 4, or 5 on the C-SSRS at Screening or at any clinic admission, or is currently at risk of suicide in the opinion of an Investigator.
  • A recent history (within 6 months prior to Screening) of substance use disorder (including alcohol) (as judged by the Investigator) or regularly consumes >2 alcoholic drinks/day during the last 3 months prior to Screening (1 alcoholic drink is approximately equivalent to: beer [284 mL], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]). Subjects who consume 3 drinks per day but less than 14 drinks per week may be enrolled at the discretion of the Investigator.
  • Demonstrates simulator sickness questionnaire scores which are indicative of simulator sickness as defined in the driving simulation operations manual.
  • Regularly consumes excessive amounts of caffeine, defined as greater than 6 servings of coffee, tea, cola, or other caffeinated beverages per day.
  • Smokes more than 10 cigarettes or e-cigarettes, or 3 cigars or pipes per day, or is unable to refrain from smoking during study visits.
  • Has been exposed to an investigational drug or device within the 30 days, or 5 half lives (if known), whichever is longer, prior to Screening.
  • Has used a prescription or over-the-counter medication known to cause sedation within 7 days prior to Admission for Period 1 and is unwilling or unable to refrain from sedating medication use during study participation.
  • Has used any benzodiazepine, barbiturate, or GABAA modulator (e.g., eszopiclone, zopiclone, zaleplon, and zolpidem) within 28 days prior to Admission for Period 1 or is unwilling or unable to refrain from medication use during study participation.
  • Has a history of hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV) antibodies 1 or 2.
  • Is pregnant or breastfeeding at Screening or any clinic admission or will attempt to become pregnant at any time during study participation.
  • Has a clinically significant abnormal finding on 6-lead electrocardiogram (ECG) at Screening or at any clinic admission. The ECG may be repeated once for confirmatory purposes if initial values obtained exceed the limits specified.
  • Has a positive urine test for drugs of abuse (other than tetrahydrocannabinol (THC)) or Breath Alcohol Concentration (BrAC) > 0.0 at Screening or any admission.
  • Has any clinically significant abnormal physical examination finding at Screening or any clinic admission.
  • Participates in night shift work.
  • Has traveled across ≥1 time zone in the 2 weeks prior to Admission for Period 1 or is expected to travel across ≥1 time zone during the study.
  • Is investigative site personnel or their immediate families (spouse, parent, child, or sibling whether biological or legally adopted).

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): NCT04970342


Locations
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United States, Iowa
National Advanced Driving Simulator
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Timothy L. Brown
National Highway Traffic Safety Administration (NHTSA)
Acclaro Research Solutions, Inc.
Cognitive Research Corporation
Investigators
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Principal Investigator: Timothy L Brown National Advanced Driving Simulator, University of Iowa
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Responsible Party: Timothy L. Brown, Director of Drugged Driving Research, University of Iowa
ClinicalTrials.gov Identifier: NCT04970342    
Other Study ID Numbers: 202105389
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data is being collected to support regulatory efforts by the government and data will not be available to those outside of the research team and government at this time.

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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 Timothy L. Brown, University of Iowa:
Driving
Cannabis
Xanax
Marijuana
Alprazolam
Driving Impairment
Substance Use
SDLP
CogScreen
CRCDS
Additional relevant MeSH terms:
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Alprazolam
Physiological Effects of Drugs
Psychotropic Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
GABA Modulators
GABA Agents