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

• Status: Completed
• Trial end date: 2021-08-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Timothy L. Brown
• Collaborators: Acclaro Research Solutions, Inc.; Cognitive Research Corporation; National Highway Traffic Safety Administration (NHTSA)
• Treatments: Alprazolam

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).