NCT04126083已完成4 期
Lofexidine for Rapid Pre-Operative Opioid Tapering in Adults Undergoing Lumbar Spine Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Opioid Tapering
研究概览
简要总结
The primary objective is to investigate the effects of lofexidine in adults undergoing opioid tapering prior to elective lumbar spine surgery.
详细描述
In this clinical trial, an open label design will be used to facilitate opioid tapering during a 12-day period prior to elective spine surgery. The primary outcome measure of this study is the number of patients who achieve a 50% reduction in daily opioid dose at day 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label design
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years.
- •Chronic lumbar spine pain for ≥ 3 months duration.
- •Scheduled for elective lumbar spine surgery.
- •Daily morphine equivalent dose between 50 mg and 200 mg.
排除标准
- •Cancer-related pain.
- •Medical or surgical conditions that could be adversely impacted by opioid tapering or use of lofexidine including, but not exclusively limited to, cardiac disease, inflammatory bowel disease, renal or hepatic impairment, vascular disease, and history of anaphylaxis. Patients may be excluded for other comorbid medical or surgical conditions based on the physician investigator's discretion.
- •History of schizophrenia or other chronic psychiatric disorder that could be adversely impacted by opioid tapering or use of lofexidine. Patients may be excluded for other comorbid mental health conditions based on the physician investigator's discretion.
- •Neurological condition that impair functioning in an ambulatory setting or could be adversely impacted by opioid tapering or use of lofexidine including, but not exclusively limited to, Parkinson's disease, amyotrophic lateral sclerosis, or a dementing illness. Patients may be excluded for other neurological conditions based on the physician investigator's discretion.
- •Active substance abuse disorder.
- •Inability to function in an ambulatory care setting due to severe deconditioning requiring use of supportive gait aids including a cane or walker. Patients may be excluded for other functional problems based on the physician investigator's discretion.
- •History of adverse effects attributed to opioid tapering or lofexidine use.
- •Use of medications from drug classes known to have adverse interactions with lofexidine including, but not exclusively limited to, beta-blockers, calcium channel blockers, alpha 1 and 2 receptor antagonists, tricyclic antidepressants, benzodiazepines, and selective serotonin reuptake inhibitors. Patients may be excluded for use of other medications based on the physician investigator's and research pharmacy's discretion.
研究组 & 干预措施
Lofexidine
Experimental
Patients will receive lofexidine 0.54 mg 4 times daily and the baseline opioid dose will be reduced by 10% daily.
干预措施: Lofexidine Oral Tablet (Drug)
结局指标
主要结局
Opioid Tapering
时间窗: 12 days
The number of patients who achieve a 50% reduction in daily opioid dose at day 12.
次要结局
未报告次要终点
研究者
W. Michael Hooten
Principal Investigator
Mayo Clinic
研究点 (1)
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