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临床试验/NCT04097743
NCT04097743终止不适用

Effect of Pain Catastrophizing on Prescription Opioid Craving

Stanford University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2021年6月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
93
试验地点
1
主要终点
Craving

研究概览

简要总结

Adherence to prescription opioid and opioid tapering as indicated are critical for safe chronic opioid therapy for chronic pain, but this can be difficult for patients experiencing prescription opioid craving. Because pain catastrophizing is proposed as a possible treatment target by our and others' preliminary results, the proposed study aims to determine whether pain catastrophizing is a treatment target to reduce prescription opioid craving and to investigate whether negative affect and stress hormones are potential mediators. The findings from the current study will inform whether a psychology intervention to lower pain catastrophizing will reduce opioid craving, and whether psychological and physical distress as well as cognitive function will be potential mediators of the treatment effect.

详细描述

Chronic pain and opioid overdose are two critical public health problems in the US. About 25 million adults (11%) suffer from chronic daily pain and up to 8 million use opioids to manage chronic pain. Unfortunately, 46 people die daily from overdose of prescription opioids. For safe chronic opioid therapy for chronic pain, physicians monitor patients' adherence to prescription opioids, and reduce or discontinue the prescription as indicated. Yet, adherence and cessation are not easy for some patients and one reason is opioid craving, a strong desire or urge to use opioids. Our preliminary data show about 34% of patients on chronic opioid therapy report craving. Craving is strongly associated with opioid misuse and negative health outcomes. To date, we do not fully understand the underlying mechanisms of prescription opioid craving in chronic pain sufferers, and psychological treatment targets to reduce craving. Based on our pilot survey, patients endorsing craving reported greater pain catastrophizing than those endorsing no craving. Our other survey study also reported a positive link between pain catastrophizing and opioid craving in patients on chronic opioid therapy for chronic pain conditions. Although these findings propose a possibility that lowering pain catastrophizing may decrease opioid craving, cross-sectional observational studies are limited in investigating a causal association. Potentially, pain catastrophizing enhances stress-induced opioid craving because stress-induced opioid craving is a well-established phenomenon in studies of addiction, and pain catastrophizing is associated with greater pain and emotional distress in patients with chronic pain. Therefore, the proposed project seeks to determine: a) the effect of pain catastrophizing on prescription opioid craving in patients on chronic opioid therapy for chronic pain and b) psychological (negative affect) and physiological (cortisol, norepinephrine) distress and cognitive function as potential mediating variables. The proposed study will use the previously validated protocol to temporarily induce and reduce pain catastrophizing and assess changes in opioid craving, negative affect, and stress hormones before and after pain catastrophizing manipulation. Additionally, this proposed study prospectively administers the protocol to reduce pain catastrophizing by thinking about and rehearsing a coping statement daily for 7 days and monitor daily opioid craving, opioid use and misuse, and negative affect for 14 days. The current project is expected to characterize the role of pain catastrophizing in opioid craving and opioid misuse, and pain catastrophizing as a critical psychological treatment target for reducing prescription opioid craving and improving prescription adherence. Furthermore, the protocol to manipulate pain catastrophizing can facilitate future research to study causal mechanisms involved in pain catastrophizing and the protocol to rapidly stabilize pain catastrophizing can be used clinically to improve the health outcome of patients taking prescription opioid for chronic 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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • At least 18 years
  • Chronic pain ( > 3months)
  • Prescription opioid use (>3 months)

排除标准

  • Current diagnosis of cancer
  • Concurrent psychological therapy
  • Other severe psychiatric conditions (schizophrenia, delusional disorder, psychotic disorder, dissociative disorder, and active suicidality)
  • Any skin conditions on the hand (pain testing site)
  • Non-English speaker
  • No access to email or smart phone

研究组 & 干预措施

Coping statement

Experimental

Daily practice of pain coping statements for 7 days

干预措施: Coping Statement (Behavioral)

Control

No Intervention

No instruction about pain coping statement.

结局指标

主要结局

Craving

时间窗: At day 14 (7 days after intervention)

Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours.

Craving

时间窗: At day 7 (after intervention)

Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours.

次要结局

  • Cortisol(At day 14 (7 days after intervention))
  • Cortisol(At day 14 (7 days after intervention))
  • Anxiety Symptoms(At day 14 (7 days after intervention))
  • Depression Symptoms(At day 14 (7 days after intervention))
  • Prescription Opioid Misuse(At day 14 (7 days after intervention))
  • Cortisol(At day 7 (after intervention))
  • Anxiety Symptoms(At day 7 (after intervention))
  • Depression Symptoms(At day 7 (after intervention))

研究者

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

Dokyoung Sophia You

Clinical Assistant Professor

Stanford University

研究点 (1)

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