ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 73 of 145 for:    Hydrocodone

Opiates and Benzodiazepines on Driving

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: NCT03447353
Recruitment Status : Completed
First Posted : February 27, 2018
Results First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy L. Brown, University of Iowa

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Driving Behavior Drug: Xanax 1Mg Tablet Drug: Norco 10Mg-325Mg Tablet Drug: Placebo Oral Tablet Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: SAFER-SIM: Opiates and Benzodiazepines on Driving
Actual Study Start Date : June 14, 2016
Actual Primary Completion Date : October 25, 2016
Actual Study Completion Date : October 25, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Alprazolam

Arm Intervention/treatment
Experimental: "Sober" or Double Placebo
Subject receives two tablets, both containing placebo
Drug: Placebo Oral Tablet
Single dose on two of the four study visits, double dose on one of the four study visits

Experimental: Active Xanax, Active Norco
Subject receives two tablets, one containing Xanax and one containing Norco
Drug: Xanax 1Mg Tablet
Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco
Other Name: Alprazolam

Drug: Norco 10Mg-325Mg Tablet
Single dose on two of the four study visits, one in conjunction with 1mg alprazolam
Other Name: hydrocodone/acetaminophen

Experimental: Active Xanax, Placebo Norco
Subject receives two tablets, one containing Xanax and one containing placebo
Drug: Xanax 1Mg Tablet
Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco
Other Name: Alprazolam

Drug: Placebo Oral Tablet
Single dose on two of the four study visits, double dose on one of the four study visits

Experimental: Placebo Xanax, Active Norco
Subject receives two tablets, one containing Norco and one containing placebo
Drug: Norco 10Mg-325Mg Tablet
Single dose on two of the four study visits, one in conjunction with 1mg alprazolam
Other Name: hydrocodone/acetaminophen

Drug: Placebo Oral Tablet
Single dose on two of the four study visits, double dose on one of the four study visits




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Lane Departures [ Time Frame: over course of each simulator drive, approximately 35 minutes per visit ]

    Total number of lane departures per drive

    The total number of lane departures across the drive were analyzed using the SAS GLM procedure.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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

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): NCT03447353


Locations
United States, Iowa
National Advanced Driving Simulator
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Timothy L. Brown
Investigators
Principal Investigator: Timothy L Brown, Ph.D. National Advanced Driving Simulator at the University of Iowa

Responsible Party: Timothy L. Brown, Associate Research Scientist/Engineer, University of Iowa
ClinicalTrials.gov Identifier: NCT03447353     History of Changes
Other Study ID Numbers: 201604731
First Posted: February 27, 2018    Key Record Dates
Results First Posted: September 27, 2018
Last Update Posted: September 27, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Timothy L. Brown, University of Iowa:
driving
Xanax
Norco
simulation

Additional relevant MeSH terms:
Acetaminophen, hydrocodone drug combination
Hydrocodone
Acetaminophen
Alprazolam
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Antitussive Agents
Respiratory System Agents