OpDrive: Use of Driving Tests to Evaluate Patient Performance on Oral Opioids

Sponsor
Asokumar Buvanendran (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00659035
Collaborator
(none)
450
1
175
2.6

Study Details

Study Description

Brief Summary

Many patients seen at Pain Centers are advised not to drive if they are on long-term opioid medications. Although such advice is routinely given considering patients' safety, unnecessary restrictions to driving can cause inconvenience to the patients and delay their treatment. Such restrictions also pose social and legal questions to patients and physicians.

The investigators would like to test such patients' ability to drive under oral opioids using a driving simulator at the Pain Center. This simulator is like a video game with computer and a steering wheel to simulate real life driving. The driving simulator provides measure on several outcome measures, such as attention, reaction time, etc. allowing us to specifically address question pertaining to any cognitive or behavioral differences.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Many patients seen at Pain Centers are advised not to drive if they are on long-term opioid medications. Although such advice is routinely given considering patients' safety, unnecessary restrictions to driving can cause inconvenience to the patients and delay their treatment. Such restrictions also pose social and legal questions to patients and physicians.

    The investigators would like to test such patients' ability to drive under oral opioids using a driving simulator at the Pain Centre. This simulator is like a video game with computer and a steering wheel to simulate real life driving. The driving simulator provides measure on several outcome measures, such as attention, reaction time, etc. allowing us to specifically address question pertaining to any cognitive or behavioral differences.

    A pilot phase, for feasibility, included 80 subjects. This phase will include a comparison with a random selection of 450 patients receiving one of the following 5 treatments:

    Group 1 (IT): Subjects receiving 1-10 mg/day of morphine or its equivalent doses of opioid medications through intrathecal route. Intrathecal medications are administered through a catheter in spinal cord

    Group 2 (Oral): Subjects receiving oral opioids (morphine, oxycodone, hydrocodone, methadone), but not also receiving anticonvulsants (gabapentin, pregabalin, topiramate), muscle relaxants, benzodiazepines, or diphenylhydramine for at least a week before testing; low dose antidepressants and/or NSAIDs are OK

    Group 3 (Oral + Anticonvulsant): Subjects receiving oral opioids (morphine, oxycodone, hydrocodone, methadone) and anticonvulsants (gabapentin, pregabalin, topiramate), but not also receiving muscle relaxants, benzodiazepines, or diphenylhydramine for at least a week before testing; low dose antidepressants and/or NSAIDs are OK

    Group 4 (Control -Pain) Subject not receiving opioid medications, anticonvulsants (gabapentin, pregabalin, topiramate), muscle relaxants, benzodiazepines, or diphenylhydramine for at least a week before testing; low dose antidepressants and/or NSAIDs are OK.

    Group 5 (Control -No Pain) Age-matched volunteers (NO PAIN) not receiving opioid medications, anticonvulsants (gabapentin, pregabalin, topiramate), muscle relaxants, benzodiazepines, or diphenylhydramine for at least a week before testing; low dose antidepressants and/or NSAIDs are OK.

    First group has 50 patients and the rest will have 100 patients each.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    450 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Use of Driving Tests to Evaluate Patient Performance on Oral Opioids
    Actual Study Start Date :
    Apr 1, 2008
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    IT

    Subjects receiving 1-10 mg/day of morphine or its equivalent doses of opioid medications through intrathecal route. Intrathecal medications are administered through a catheter in spinal cord

    Oral

    Subjects receiving oral opioids (morphine, oxycodone, hydrocodone, methadone), but not also receiving anticonvulsants (gabapentin, pregabalin, topiramate), muscle relaxants, benzodiazepines, or diphenylhydramine for at least a week before testing; low dose antidepressants and/or NSAIDs are OK

    Oral + Anticonvulsant

    Subjects receiving oral opioids (morphine, oxycodone, hydrocodone, methadone) and anticonvulsants (gabapentin, pregabalin, topiramate), but not also receiving muscle relaxants, benzodiazepines, or diphenylhydramine for at least a week before testing; low dose antidepressants and/or NSAIDs are OK

    Control -Pain

    Subject not receiving opioid medications, anticonvulsants (gabapentin, pregabalin, topiramate), muscle relaxants, benzodiazepines, or diphenylhydramine for at least a week before testing; low dose antidepressants and/or NSAIDs are OK.

    Control -No Pain

    Age-matched volunteers (NO PAIN) not receiving opioid medications, anticonvulsants (gabapentin, pregabalin, topiramate), muscle relaxants, benzodiazepines, or diphenylhydramine for at least a week before testing; low dose antidepressants and/or NSAIDs are OK.

    Outcome Measures

    Primary Outcome Measures

    1. Weaving, measured as standard deviation of lateral position. [1 h]

    Secondary Outcome Measures

    1. Reaction time [1 h]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Driving license
    Exclusion Criteria:
    • Any other drug or condition that would impair driving ability

    • History of seizures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rush University Medical Center Chicago Illinois United States 60612

    Sponsors and Collaborators

    • Asokumar Buvanendran

    Investigators

    • Principal Investigator: Asokumar Buvanendran, MD, Rush University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Asokumar Buvanendran, Attending Physician, Associate Professor, Rush University Medical Center
    ClinicalTrials.gov Identifier:
    NCT00659035
    Other Study ID Numbers:
    • ABuv111407
    First Posted:
    Apr 16, 2008
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Keywords provided by Asokumar Buvanendran, Attending Physician, Associate Professor, Rush University Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 28, 2022