- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00659035
Use of Driving Tests to Evaluate Patient Performance on Oral Opioids (OpDrive)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Driving license
Exclusion Criteria:
- Any other drug or condition that would impair driving ability
- History of seizures
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weaving, measured as standard deviation of lateral position.
Time Frame: 1 h
|
1 h
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reaction time
Time Frame: 1 h
|
1 h
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Asokumar Buvanendran, MD, Rush University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABuv111407
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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