Driving BehaviorPhase 4NCT03447353
Opiates and Benzodiazepines on Driving
A Phase 4 study testing Xanax 1Mg Tablet and Norco 10Mg-325Mg Tablet in people with Driving Behavior, run by Timothy L. Brown at 1 site in United States.
Trial summary
The aim of this research is to assess drug effects (Xanax and Norco) on driving performance. Researchers will use the Alertness Memory Profiler (AMP) application to compare results to previous related studies. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Driving Behavior
- What is being tested?
- Xanax 1Mg Tablet and Norco 10Mg-325Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2016to 25 Oct 2016
- Phase
- Phase 4
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult men and women, based on medical and psychological evaluation
- Currently valid unrestricted (except for vision correction) US driver's license
- Licensed driver for at least the past two years
- Drove at least 5000 miles in the past year, by self-report
- Live within a 60 mile radius of NADS
- Available for five study sessions, with one being approximately 2 hours and four being approximately 5-6 hours
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- Peripheral veins suitable for repeated venipuncture
- Systolic blood pressure within a clinically normal range (120 ± 30 mmHg) and diastolic blood pressure of 80 ± 20 mmHg
- Good command of written and spoken English
- Female subjects with reproductive potential must agree to use (and/or have their partner use) one (1) acceptable method of birth control beginning at the screening visit throughout the study (including intervals between treatment periods/panels) and until 2 weeks after the last dose of study drug in the last treatment period. Acceptable methods of birth control include the following: intrauterine device (IUD-with or without local hormone release), diaphragm, spermicides, cervical cap, contraceptive sponge, oral contraceptives or condoms. Abstinence is an alternative lifestyle and subjects practicing abstinence may be included in the study.
Who cannot join
- Requires any special equipment to help drive, such as pedal extensions, hand brake or throttle, spinner wheel knobs, or other non-standard equipment
- Presence of any clinically significant illness, as detected by history, physical examination, and/or laboratory tests, that might influence driving performance (e.g., seizures, sleep apnea, narcolepsy, vertigo, chronic fatigue syndrome) or put the subject at increased risk of adverse events (e.g., cardiac arrhythmia, hypertension)
- If female, pregnant or nursing
- Currently taking drugs that are contraindicated for use with study drugs
- Significant history of motion sickness or demonstrates significant simulator sickness during practice drives at screening (SSQ). Subjects must have scores below the following values on the SSQ: Nausea < 21, Oculomotor <32, Disorientation < 15, and Total Score < 32.
- History of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject from study participation
- Prior participation in a driver impairment or distraction-related research study conducted at NADS that uses the same base drive
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: SAFER-SIM: Opiates and Benzodiazepines on Driving
The aim of this research is to assess drug effects (Xanax and Norco) on driving performance. Researchers will use the Alertness Memory Profiler (AMP) application to compare results to previous related studies.
This study continues a line of research designed to characterize the effects of common recreationally used prescription and illicit drugs with well known stimulant and sedating effects and their relationship to results from the Alertness Memory Profiler (AMP) that included a set of vigilance and memory tasks.
Read the detailed description
This study uses EEG, EKG, computerized assessment, blood sampling, and driving simulation.
Individuals recruited will be normal, healthy individuals not currently taking the study drugs. The study will involve five visits, a screening visit as well as four dosing visits. The dosing visits will have a clean (double placebo) and three drugged visits (Xanax and Norco placebo, Xanax placebo and Norco, Xanax and Norco). The screening visit will last about two hours and will include drug and pregnancy testing as well as screening for physical/psychological health. Each of the dosing visits will last approximately five to six hours and will include sleep and food intake surveys, being dosed with study drugs or placebos, AMP assessments, a simulator drive, and wellness surveys. There will also be 4 mL blood sampling before dosing, before driving, and after driving.
- Conditions
- Driving Behavior
- Being tested
- Xanax 1Mg Tablet, Norco 10Mg-325Mg Tablet, Placebo Oral Tablet
- Keywords
- driving, Xanax, Norco, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanax 1Mg TabletDrug
Also called Alprazolam
Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco
Norco 10Mg-325Mg TabletDrug
Also called hydrocodone/acetaminophen
Single dose on two of the four study visits, one in conjunction with 1mg alprazolam
Placebo Oral TabletDrug
Single dose on two of the four study visits, double dose on one of the four study visits
| Study group | Role | What they receive |
|---|---|---|
| "Sober" or Double Placebo | Experimental | Subject receives two tablets, both containing placebo Receives: Drug: Placebo Oral Tablet |
| Active Xanax, Active Norco | Experimental | Subject receives two tablets, one containing Xanax and one containing Norco Receives: Drug: Xanax 1Mg Tablet; Drug: Norco 10Mg-325Mg Tablet |
| Active Xanax, Placebo Norco | Experimental | Subject receives two tablets, one containing Xanax and one containing placebo Receives: Drug: Xanax 1Mg Tablet; Drug: Placebo Oral Tablet |
| Placebo Xanax, Active Norco | Experimental | Subject receives two tablets, one containing Norco and one containing placebo Receives: Drug: Norco 10Mg-325Mg Tablet; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
SDLP
Standard Deviation of Lane Position
Standard deviation of lane position was analyzed using the SAS GLM function to identify changes in driver performance. Values represents means across the driving environments studied.
Measured: over course of each simulator drive, approximately 35 minutes per visit
Secondary outcomes (1)
Lane Departures
Total number of lane departures per drive
The total number of lane departures across the drive were analyzed using the SAS GLM procedure.
Measured: over course of each simulator drive, approximately 35 minutes per visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start14 Jun 2016
- Primary completion25 Oct 2016
- Study completion25 Oct 2016
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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy L. Brown
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Timothy L. Brown, University of Iowa
- Investigators
- Timothy L Brown, Ph.D., Principal investigator, National Advanced Driving Simulator at the University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447353
- Sponsor's protocol ID
- 201604731
- Status last verified
- Apr 2018
- First submitted
- 7 Feb 2018
- Last updated
- 27 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFER-SIM: Opiates and Benzodiazepines on Driving
- ClinicalTrials.gov ID
- NCT03447353
- Acronym / sponsor ID
- 201604731
- Conditions
- Driving Behavior
- Keywords
- driving, Xanax, Norco, simulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Timothy L. BrownUniversity, hospital or other
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 25 Oct 2016 (actual)
- Study completion
- 25 Oct 2016 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Posted 27 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this research is to assess drug effects (Xanax and Norco) on driving performance. Researchers will use the Alertness Memory Profiler (AMP) application to compare results to previous related studies.
This study continues a line of research designed to characterize the effects of common recreationally used prescription and illicit drugs with well known stimulant and sedating effects and their relationship to results from the Alertness Memory Profiler (AMP) that included a set of vigilance and memory tasks.
Detailed description
This study uses EEG, EKG, computerized assessment, blood sampling, and driving simulation.
Individuals recruited will be normal, healthy individuals not currently taking the study drugs. The study will involve five visits, a screening visit as well as four dosing visits. The dosing visits will have a clean (double placebo) and three drugged visits (Xanax and Norco placebo, Xanax placebo and Norco, Xanax and Norco). The screening visit will last about two hours and will include drug and pregnancy testing as well as screening for physical/psychological health. Each of the dosing visits will last approximately five to six hours and will include sleep and food intake surveys, being dosed with study drugs or placebos, AMP assessments, a simulator drive, and wellness surveys. There will also be 4 mL blood sampling before dosing, before driving, and after driving.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| "Sober" or Double Placebo | Experimental | Drug: Placebo Oral TabletSubject receives two tablets, both containing placebo |
| Active Xanax, Active Norco | Experimental | Drug: Xanax 1Mg Tablet, Drug: Norco 10Mg-325Mg TabletSubject receives two tablets, one containing Xanax and one containing Norco |
| Active Xanax, Placebo Norco | Experimental | Drug: Xanax 1Mg Tablet, Drug: Placebo Oral TabletSubject receives two tablets, one containing Xanax and one containing placebo |
| Placebo Xanax, Active Norco | Experimental | Drug: Norco 10Mg-325Mg Tablet, Drug: Placebo Oral TabletSubject receives two tablets, one containing Norco and one containing placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy adult men and women, based on medical and psychological evaluation
- Currently valid unrestricted (except for vision correction) US driver's license
- Licensed driver for at least the past two years
- Drove at least 5000 miles in the past year, by self-report
- Live within a 60 mile radius of NADS
Key exclusion criteria (7 listed)
- Requires any special equipment to help drive, such as pedal extensions, hand brake or throttle, spinner wheel knobs, or other non-standard equipment
- Presence of any clinically significant illness, as detected by history, physical examination, and/or laboratory tests, that might influence driving performance (e.g., seizures, sleep apnea, narcolepsy, vertigo, chronic fatigue syndrome) or put the subject at increased risk of adverse events (e.g., cardiac arrhythmia, hypertension)
- If female, pregnant or nursing
- Currently taking drugs that are contraindicated for use with study drugs
- Significant history of motion sickness or demonstrates significant simulator sickness during practice drives at screening (SSQ). Subjects must have scores below the following values on the SSQ: Nausea < 21, Oculomotor <32, Disorientation < 15, and Total Score < 32.
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 |
|---|---|---|
| Xanax 1Mg TabletAlso: AlprazolamSingle dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco | Drug | Active Xanax, Active Norco, Active Xanax, Placebo Norco |
| Norco 10Mg-325Mg TabletAlso: hydrocodone/acetaminophenSingle dose on two of the four study visits, one in conjunction with 1mg alprazolam | Drug | Active Xanax, Active Norco, Placebo Xanax, Active Norco |
| Placebo Oral TabletSingle dose on two of the four study visits, double dose on one of the four study visits | Drug | "Sober" or Double Placebo, Active Xanax, Placebo Norco, Placebo Xanax, Active Norco |
Primary outcome
SDLP
Time frame: over course of each simulator drive, approximately 35 minutes per visit
Standard Deviation of Lane Position Standard deviation of lane position was analyzed using the SAS GLM function to identify changes in driver performance. Values represents means across the driving environments studied.
1 secondary outcome
Lane Departures
Time frame: over course of each simulator drive, approximately 35 minutes per visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, Ph.D. principal investigator
National Advanced Driving Simulator at the 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 4 study testing Xanax 1Mg Tablet and Norco 10Mg-325Mg Tablet in people with Driving Behavior, 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 7 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 27 Sep 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 27 Sep 2018). 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?
SDLP (time frame: over course of each simulator drive, approximately 35 minutes per visit). 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 27 Sep 2018.