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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Asokumar Buvanendran, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00659035
First received: January 30, 2008
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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 Phase
Chronic Pain
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Use of Driving Tests to Evaluate Patient Performance on Oral Opioids

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Weaving, measured as standard deviation of lateral position. [ Time Frame: 1 h ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reaction time [ Time Frame: 1 h ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: April 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pain Clinic population

Criteria

Inclusion Criteria:

  • Driving license

Exclusion Criteria:

  • Any other drug or condition that would impair driving ability
  • History of seizures
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659035

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Asokumar Buvanendran
Investigators
Principal Investigator: Asokumar Buvanendran, MD Rush University Medical Center
  More Information

No publications provided

Responsible Party: Asokumar Buvanendran, Attending Physician, Associate Professor, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00659035     History of Changes
Other Study ID Numbers: ABuv111407
Study First Received: January 30, 2008
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
driving
opioids
impairment
ability
patients
receiving
oral morphine
severe

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anticonvulsants
Analgesics, Opioid
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014