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临床试验/NCT00659035
NCT00659035
进行中(未招募)
不适用

Use of Driving Tests to Evaluate Patient Performance on Oral Opioids

Asokumar Buvanendran1 个研究点 分布在 1 个国家目标入组 450 人2008年4月1日
适应症Chronic Pain

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Chronic Pain
发起方
Asokumar Buvanendran
入组人数
450
试验地点
1
主要终点
Weaving, measured as standard deviation of lateral position.
状态
进行中(未招募)
最后更新
3个月前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2008年4月1日
结束日期
2026年12月1日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

发起方
Asokumar Buvanendran
责任方
Sponsor Investigator
主要研究者

Asokumar Buvanendran

Attending Physician, Associate Professor

Rush University Medical Center

入排标准

入选标准

  • Driving license

排除标准

  • Any other drug or condition that would impair driving ability
  • History of seizures

结局指标

主要结局

Weaving, measured as standard deviation of lateral position.

时间窗: 1 h

次要结局

  • Reaction time(1 h)

研究点 (1)

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