Driving BehaviorPhase 1PDIDNCT04970342
Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim
A Phase 1 study testing 0.75 mg Alprazolam Capsule, Cannabis (6.18% THC / <0.025% CBD) and Cannabis (0%/ THC / 0% CBD) in people with Driving Behavior and Driving Under the Influence, run by Timothy L. Brown at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Driving Behavior, Driving Under the Influence
- What is being tested?
- 0.75 mg Alprazolam Capsule, Cannabis (6.18% THC / <0.025% CBD) and Cannabis (0%/ THC / 0% CBD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2021to 21 Aug 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 (On practice scenario, SDLP no higher than 1 standard deviation greater than the mean for normal healthy adults completing the practice scenario and subject has 7 or more correct hits on the Divided Attention task; CogScreen SDC Correct no less than 1 standard deviation below the mean for healthy adults); 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.
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- Possesses (and is willing to provide) a valid driver's license and is an active driver.
- Determined to be (by self-report) an active cannabis user with use of at least once per month over the preceding 90 days.
- Willing to abstain from cannabis use (other than study drug) beginning at the end of Screening until discharge from NADS on Day 2 of Treatment 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Advanced Driving Simulator
Iowa City, Iowa, 52242
About this study
Official title: Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim: Evaluating Sensitivity to the Effects of Cannabis and Alprazolam
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.
Read the 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. Each randomized subject will complete a treatment visit of each type one week apart in a counterbalanced sequence.
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.
- Conditions
- Driving Behavior, Driving Under the Influence
- Being tested
- Placebo (Lactose) Capsule, 0.75 mg Alprazolam Capsule, Cannabis (6.18% THC / <0.025% CBD), Cannabis (0%/ THC / 0% CBD)
- Keywords
- Driving, Cannabis, Xanax, Marijuana, Alprazolam, Driving Impairment, Substance Use, SDLP, CogScreen, CRCDS
- Medical subject headings
- Driving Under the Influence, Marijuana Abuse, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (Lactose) CapsuleDrug
Also called Placebo, Placebo Alprazolam
Single dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose
0.75 mg Alprazolam CapsuleDrug
Also called Xanax, Active Alprazolam, Active Xanax
Single dose on one of the three study visits, orally administered 40 minutes prior to cannabis dose
Cannabis (6.18% THC / <0.025% CBD)Drug
Also called Marijuana, Marihuana, Active Cannabis
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.
Cannabis (0%/ THC / 0% CBD)Drug
Also called Marijuana, Marihuana, Placebo Cannabis, Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| "Sober" or Double Placebo | Experimental | Subject receives alprazolam capsule containing placebo (lactose). Subject receives placebo cannabis (0% THC / 0% CBD). Receives: Drug: Placebo (Lactose) Capsule; Drug: Cannabis (0%/ THC / 0% CBD) |
| Active Alprazolam (Xanax), Placebo Cannabis | Experimental | Subject receives active 0.75 mg alprazolam capsule. Subject receives placebo cannabis (0% THC / 0% CBD). Receives: Drug: 0.75 mg Alprazolam Capsule; Drug: Cannabis (0%/ THC / 0% CBD) |
| Placebo Alprazolam (Xanax), Active Cannabis | Experimental | Subject receives alprazolam capsule containing placebo (lactose). Subject receives active cannabis (6.18% THC / <0.025% CBD). Receives: Drug: Placebo (Lactose) Capsule; Drug: Cannabis (6.18% THC / <0.025% CBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Deviation of Lateral Position (SDLP)
The ability to keep the vehicle straight in the lane. Data is presented from the a rural drive with a concurrent divided attention task.
Measured: over one hour during the course of the simulator drive conducted 45 minutes post-dose at Treatment Visit 1, 2, and 3
Secondary outcomes (1)
Lane Exceedences
Count of the number of times the simulated vehicle leaves the driving lane, will be compared across treatments. Data is from a rural drive with a concurrent divided attention task.
Measured: over one hour during the course of the simulator drive conducted 45 minutes post-dose at Treatment Visit 1, 2, and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start16 Jul 2021
- Primary completion21 Aug 2021
- Study completion21 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Driving BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study uses two treatments - alprazolam and cannabis - and placebo. Subjects are randomized to a study sequence where the order of treatments (study arm) 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy L. Brown
- Sponsor type
- University, hospital or other
- Collaborators
- National Highway Traffic Safety Administration (NHTSA), Acclaro Research Solutions, Inc., Cognitive Research Corporation
- Responsible party
- Sponsor-investigator, Timothy L. Brown, University of Iowa
- Investigators
- Timothy L Brown, Principal investigator, National Advanced Driving Simulator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970342
- Sponsor's protocol ID
- 202105389
- Acronym
- PDID
- Status last verified
- Aug 2022
- First submitted
- 24 Jun 2021
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim: Evaluating Sensitivity to the Effects of Cannabis and Alprazolam
- ClinicalTrials.gov ID
- NCT04970342
- Acronym / sponsor ID
- PDID / 202105389
- Conditions
- Driving Behavior, Driving Under the Influence
- Keywords
- Driving, Cannabis, Xanax, Marijuana, Alprazolam, Driving Impairment, Substance Use, SDLP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Timothy L. BrownUniversity, hospital or other
- Collaborators
- National Highway Traffic Safety Administration (NHTSA), Acclaro Research Solutions, Inc., Cognitive Research Corporation
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 21 Aug 2021 (actual)
- Study completion
- 21 Aug 2021 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Posted 25 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Each randomized subject will complete a treatment visit of each type one week apart in a counterbalanced sequence.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study uses two treatments - alprazolam and cannabis - and placebo. Subjects are randomized to a study sequence where the order of treatments (study arm) 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.
| Arm | Type | Receives |
|---|---|---|
| "Sober" or Double Placebo | Experimental | Drug: Placebo (Lactose) Capsule, Drug: Cannabis (0%/ THC / 0% CBD)Subject receives alprazolam capsule containing placebo (lactose). Subject receives placebo cannabis (0% THC / 0% CBD). |
| Active Alprazolam (Xanax), Placebo Cannabis | Experimental | Drug: 0.75 mg Alprazolam Capsule, Drug: Cannabis (0%/ THC / 0% CBD)Subject receives active 0.75 mg alprazolam capsule. Subject receives placebo cannabis (0% THC / 0% CBD). |
| Placebo Alprazolam (Xanax), Active Cannabis | Experimental | Drug: Placebo (Lactose) Capsule, Drug: Cannabis (6.18% THC / <0.025% CBD)Subject receives alprazolam capsule containing placebo (lactose). Subject receives active cannabis (6.18% THC / <0.025% CBD). |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo (Lactose) CapsuleAlso: Placebo, Placebo AlprazolamSingle dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose | Drug | "Sober" or Double Placebo, Placebo Alprazolam (Xanax), Active Cannabis |
| 0.75 mg Alprazolam CapsuleAlso: Xanax, Active Alprazolam, Active XanaxSingle dose on one of the three study visits, orally administered 40 minutes prior to cannabis dose | Drug | Active Alprazolam (Xanax), Placebo Cannabis |
| Cannabis (6.18% THC / <0.025% CBD)Also: Marijuana, Marihuana, Active CannabisCannabis 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. | Drug | Placebo Alprazolam (Xanax), Active Cannabis |
| Cannabis (0%/ THC / 0% CBD)Also: Marijuana, Marihuana, Placebo Cannabis, PlaceboCannabis 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. | Drug | "Sober" or Double Placebo, Active Alprazolam (Xanax), Placebo Cannabis |
Primary outcome
Standard Deviation of Lateral Position (SDLP)
Time frame: over one hour during the course of the simulator drive conducted 45 minutes post-dose at Treatment Visit 1, 2, and 3
The ability to keep the vehicle straight in the lane. Data is presented from the a rural drive with a concurrent divided attention task.
1 secondary outcome
Lane Exceedences
Time frame: over one hour during the course of the simulator drive conducted 45 minutes post-dose at Treatment Visit 1, 2, and 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy L Brown principal investigator
National Advanced Driving Simulator, University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.75 mg Alprazolam Capsule, Cannabis (6.18% THC / <0.025% CBD) and Cannabis (0%/ THC / 0% CBD) in people with Driving Behavior and Driving Under the Influence, run by Timothy L. Brown at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard Deviation of Lateral Position (SDLP) (time frame: over one hour during the course of the simulator drive conducted 45 minutes post-dose at Treatment Visit 1, 2, and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.