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临床试验/NCT03298269
NCT03298269已完成不适用

Behavioral Interventions for Chronic Pain and Opioid-Related Problems

University of Utah2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2017年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
2
主要终点
Change in pain symptoms

研究概览

简要总结

The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery Enhancement versus a social support group (supportive counseling) intervention for chronic pain patients receiving long-term opioid pharmacotherapy for pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-60+
  • Current chronic pain condition
  • Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days

排除标准

  • Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention
  • Active suicidality, schizophrenia, psychotic disorder, and/or severe substance dependence (other than opioid dependence)
  • Opioid misuse as determined by Current Opioid Misuse Measure

结局指标

主要结局

Change in pain symptoms

时间窗: Change from baseline through study completion (9 months post-treatment)

Pain severity and interference as measured by the Brief Pain Inventory

Change in aberrant drug-related behaviors

时间窗: Change from baseline through study completion (9 months post-treatment)

Aberrant drug-related behaviors as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen

次要结局

  • Change in opioid craving(Change from baseline through study completion (9 months post-treatment))
  • Change in interoceptive awareness(Change from baseline through 8 weeks)
  • Change in emotional distress(Change from baseline through study completion (9 months post-treatment))
  • Change in opioid dose(Change from baseline through study completion (9 months post-treatment))
  • Change in savoring(Change from baseline through 8 weeks)
  • Change in meditative experiences(Change from baseline through 8 weeks)
  • Change in reappraisal(Change from baseline through 8 weeks)
  • Change in body sensations(Change from baseline through 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Garland

Professor

University of Utah

研究点 (2)

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