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临床试验/NCT04190563
NCT04190563已完成不适用

Affective and Inflammatory Reactivity to Pain in Opioid Use Disorder

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2021年5月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
Craving

研究概览

简要总结

The goal of this study is to investigate the association between response to pain and opioid craving in people with opioid use disorder. In this study, adults with opioid use disorder will be randomized to one of two brief education sessions followed by an assessment of response to pain. Investigators will test the association between response to pain and opioid craving.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

盲法说明

The investigator and data analyst will be blind to study condition.

入排标准

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

入选标准

  • •age 18 years or older;
  • •diagnosis of opioid use disorder
  • •chronic pain
  • •ability to read and provide informed consent

排除标准

  • •major psychiatric or medical condition that would interfere with participation
  • •current opioid withdrawal
  • •currently receiving opioid analgesic medication for pain
  • •recent history of myocardial infarction or other serious cardiovascular condition
  • •current peripheral neuropathy, active vasculitis or severe peripheral vascular disease
  • •systematic inflammatory or autoimmune disorder
  • •admitted to current treatment episode on an involuntary status

研究组 & 干预措施

Pain De-Catastrophizing

Experimental

Brief behavioral education on how to modify the interpretation of pain.

干预措施: Pain De-Catastrophizing (Behavioral)

Pain Education

Placebo Comparator

Brief behavioral education on pain.

干预措施: Pain Education (Behavioral)

结局指标

主要结局

Craving

时间窗: immediately after the intervention

Investigators will assess opioid craving using the Opioid Craving Scale, a participant-reported measure of opioid craving. This is a continuous measure that is quantified as a total scale score representing an average of the 3 items, with a range from 0-10, with higher scores reflecting more craving. This outcome is the mean score at a single time point, immediately following completion of the intervention.

次要结局

未报告次要终点

研究者

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

McHugh, R. Kathryn

Assistant Professor

Mclean Hospital

研究点 (1)

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