Pilot Randomized Trial of Prescription Opioid Taper Support

描述(申请人提供)：处方类阿片类药物滥用是增长最快的药物滥用形式。处方类阿片类药物意外过量是意外死亡增长最快的原因，在8个州超过了机动车事故。这些趋势与慢性阿片类药物(COT)用于慢性非癌症疼痛(CNCP)的使用增加同步，目前估计有1000万接受者，占美国人口的3%。接触处方阿片类药物会以依赖剂量和持续时间的方式增加滥用和过量服药的风险。目前尚不清楚超过4个月的COT是否真的改善了疼痛、情绪或功能。接触处方阿片类药物会以依赖剂量和持续时间的方式增加滥用和过量服药的风险。减少阿片类药物的剂量可能会降低这些风险，而不会显著恶化疼痛、情绪和功能。然而，在接受CNCP治疗的患者中，还没有测试过减少COT的方案。研究目标：拟议的研究将开发、论证处方阿片类药物锥形支持干预的可行性，并在随机对照试验中进行试点试验。这一干预措施旨在防止在没有当前药物滥用证据的情况下接受COT治疗的CNCP患者滥用阿片类药物和不良事件。该项目将提供规划未来更大规模随机对照试验所必需的信息，旨在评估干预措施在预防接受COT治疗的CNCP患者中处方阿片类药物滥用、误用、过量和其他不良事件的有效性，并评估干预措施对阿片类药物使用、疼痛、疼痛相关活动干预和情绪的影响。具体目标1： 制定和制作为期22周的处方阿片类药物逐渐减少支持干预措施，由护士护理经理在止痛药/精神病学医生和疼痛心理学家的监督和咨询下实施。这项干预措施将包括四个部分：a)互动视频和激励性访谈干预；b)个体化、灵活、阿片类药物减量；c)疼痛自我管理培训；d)个人精神药理学咨询和计划。具体目标2：证明与通常的阿片类药物处方护理相比，在阿片类药物逐渐减少支持干预的RCT中招募和留住接受COT进行CNCP治疗的患者是可行的。具体目标3：获得关于这种方法的有效性的试点数据 处方阿片类药物缩减支持干预措施：a)在接受COT治疗的CNCP患者中实现阿片类药物剂量的持续减少，b)减少阿片类药物的滥用和阿片类药物的不良反应，以及c)改善患者的疼痛、疼痛相关活动干预和情绪。影响：拟议的试点试验将有助于确定一项更大规模的随机试验的可行性，以评估有支持的处方阿片类药物缩减干预在减少阿片类药物滥用、滥用和过量方面的有效性。它还将表明是否可以在不显著恶化疼痛、情绪和活动的情况下实现这些目标。 公共卫生相关性：处方阿片类药物滥用是增长最快的药物滥用形式。处方类阿片类药物意外过量是意外死亡增长最快的原因，在8个州超过了机动车事故。这项研究将开发、论证可行性，并初步估计支持的处方阿片类药物逐渐减少干预作为在专业疼痛诊所接受慢性非癌症疼痛的慢性阿片类药物治疗的患者中阿片类药物滥用和误用的二级预防策略的有效性。

DESCRIPTION (provided by applicant): Prescription opioid abuse is the fastest growing form of drug abuse. Accidental overdose with prescription opioids is the fastest growing cause of accidental death, exceeding motor vehicle accidents in 8 states. These trends run parallel to increases in use of chronic opioid therapy (COT) for chronic non-cancer pain (CNCP), now estimated at 10 million recipients or 3% of the US population. Exposure to prescription opioids increases risk for abuse and overdose in a dose and duration-dependent manner. It is not known if COT beyond 4 months actually improves pain, mood or function. Exposure to prescription opioids increases risk for abuse and overdose in a dose and duration-dependent manner. It is possible that decreasing opioid dose may reduce these risks without significant worsening of pain, mood, and function. However, no protocol for taper of COT among patients treated for CNCP has been tested. Research Goals: The proposed research will develop, demonstrate the feasibility of, and pilot test in an RCT a prescription opioid taper support intervention. This intervention aims to prevent opioid misuse and adverse events among patients receiving COT for CNCP without evidence of current substance abuse. The project will yield information essential to planning a future, larger-scale RCT designed to evaluate the efficacy of the intervention in preventing prescription opioid abuse, misuse, overdose and other adverse events among patients receiving COT for CNCP, and to evaluate the effects of the intervention on opioid use, pain, pain- related activity interference, and mood. Specific Aim 1: To develop and manualize a 22-week prescription opioid taper support intervention administered by a nurse care manager with supervision and consultation by a pain medicine/psychiatry physician and pain psychologist. This intervention will include four components: a) an engagement video and motivational interviewing intervention; b) an individualized, flexible, opioid taper; c) pain self-management training; and d) an individual psychopharmacology consultation and plan. Specific Aim 2: To demonstrate that it is feasible to recruit and retain patients receiving COT for CNCP in an RCT of an opioid taper support intervention compared to usual opioid prescribing care. Specific Aim 3: To obtain pilot data concerning the efficacy of this prescription opioid taper support intervention in: a) attaining sustained opioid dose reduction among patients receiving COT for CNCP, b) reducing opioid misuse and opioid adverse effects; and c) improving patient pain, pain-related activity interference, and mood. Impact: The proposed pilot trial will help determine the feasibility of a larger randomized trial to evaluate te efficacy of a supported prescription opioid taper intervention in reducing opioid misuse, abuse and overdose. It will also suggest whether these goals can be achieved without significant worsening of pain, mood and activity. PUBLIC HEALTH RELEVANCE: Prescription opioid abuse is the fastest growing form of drug abuse. Accidental overdose with prescription opioids is the fastest growing cause of accidental death, exceeding motor vehicle accidents in 8 states. This research will develop, demonstrate feasibility, and obtain preliminary estimates of efficacy of a supported prescription opioid taper intervention as a secondary prevention strategy for opioid abuse and misuse among patients receiving chronic opioid therapy for chronic non-cancer pain in a specialty pain clinic.