Long-term Opioid Management of Chronic Pain: Trends and Risks

描述(申请人提供)：数百万美国人接受长期阿片类药物治疗慢性非恶性疼痛。人们对这种治疗方案的决定因素和风险知之甚少。这项研究的重点是背部疼痛作为一种示踪条件。将使用保健服务、研究和流行病学方法来了解谁接受了长期阿片类药物治疗，并评估相关风险，包括阿片类药物滥用的开始和死亡率。这项研究将在两个大型非营利性健康计划中进行，服务于超过1%的美国人口。研究目标-我们的目标是促进关于慢性疼痛患者长期服用阿片类药物治疗的决定因素和风险的知识。目的1--审查趋势：我们将描述1995-2006年参与的健康计划中长期阿片类药物治疗的使用趋势，并确定表明临床复杂性和既往药物滥用的患者特征与长期使用阿片类药物的趋势之间的关系。目标2-评估阿片类药物滥用的风险：我们将评估长期接受阿片类药物治疗的人中阿片类药物滥用的风险因素。主要假设是：1)在接受长期阿片类药物治疗的背痛患者中，与长期使用短效阿片类药物相比，使用长效阿片类药物与降低阿片类药物滥用和误用的风险有关。2)既往的药物滥用史会增加长期接受阿片类药物治疗的背痛患者滥用和误用阿片类药物的风险。这些假说将通过比较新发病例和对照(N=600)的病例对照研究来检验。目的3-评估死亡率和其他不良事件风险：我们将评估长期阿片类药物治疗是否会增加死亡率和其他不良事件风险。主要假设是：1)长期使用阿片类药物治疗背部疼痛将与死亡率增加有关。2)与长期使用短效阿片类药物相比，长期使用长效阿片类药物会增加死亡风险。3)既往的药物滥用史与长期接受阿片类药物治疗的人的死亡率增加有关。我们将通过病例队列研究(N=1600)来评估这些假设。我们将通过研究长期阿片类药物治疗对其他不良事件的影响来扩展这些分析，这些不良事件包括：全原因和阿片类药物相关住院；阿片类药物过量；以及公认的情绪障碍的发病。

DESCRIPTION (provided by applicant): Several million Americans receive long-term opioid therapy for chronic non-malignant pain. Little is known about the determinants and risks of this treatment regimen. This research focuses on back pain as a tracer condition. Health services research and epidemiologic methods will be used to understand who receives long-term opioid therapy and to assess associated risks including onset of opioid abuse and mortality. This research will be conducted in two large, non-profit health plans serving over 1% of the U.S. population. Research goals - Our goals are to advance knowledge concerning determinants and risks of long-term opioid therapy among chronic pain patients. Aim 1-Examine trends: We will describe trends in use of long-term opioid therapy in the participating health plans from 1995-2006 and determine how patient characteristics indicating clinical complexity and prior substance abuse are related to trends in long-term opioid use. Aim 2-Assess risks of opioid abuse: We will assess risk factors for opioid abuse among persons receiving long-term opioid therapy. Primary hypotheses are: 1) Among persons receiving long-term opioid therapy for back pain, use of long-acting opioids is associated with reduced risks of onset of opioid abuse and misuse relative to long-term use of short-acting opioids. 2) A prior history of drug abuse will increase risks of opioid abuse and misuse among those receiving long-term opioid therapy for back pain. These hypotheses will be tested through a case-control study comparing recent onset cases to controls (N=600). Aim 3-Assess mortality and other adverse event risks: We will assess whether mortality and other adverse event risks are increased by long-term opioid therapy. Primary hypotheses are: 1) Long-term use of opioids for back pain will be associated with increased mortality. 2) Long-term use of long-acting opioids will increase mortality risk relative to long-term use of short-acting opioids. 3) A prior history of substance abuse will be associated with increased mortality among persons receiving long-term opioid therapy. We will evaluate these hypotheses through a case-cohort study (N=1600). We will extend these analyses by studying the effects of long-term opioid therapy on other adverse events including: all-cause and opioid-related hospitalization; opioid overdose; and onset of recognized mood disorder.