Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00659035 |
| Other study ID # |
ABuv111407 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2008 |
| Est. completion date |
November 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Rush University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
