Pilot Randomized Trial of Prescription Opioid Taper Support

描述（由申请人提供）：处方阿片类药物滥用是增长最快的药物滥用形式。处方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治疗（COT）用于慢性非癌症疼痛（CNCP）的增加平行，目前估计有1000万接受者或美国人口的3%。暴露于处方阿片类药物会以剂量和持续时间依赖性方式增加滥用和过量的风险。目前尚不清楚COT超过4个月是否真的能改善疼痛、情绪或功能。暴露于处方阿片类药物会以剂量和持续时间依赖性方式增加滥用和过量的风险。减少阿片类药物剂量可能会降低这些风险，而不会显着恶化疼痛，情绪和功能。然而，尚未对接受CNCP治疗的患者中COT逐渐减少的方案进行测试。研究目标：拟议的研究将开发、证明处方阿片类药物减量支持干预的可行性，并在RCT中进行试点测试。这项干预措施旨在预防接受COT治疗CNCP的患者中阿片类药物滥用和不良事件，而没有当前药物滥用的证据。该项目将产生计划未来更大规模RCT所必需的信息，该RCT旨在评价干预措施在预防接受COT治疗CNCP的患者中处方阿片类药物滥用、误用、过量和其他不良事件方面的疗效，并评价干预措施对阿片类药物使用、疼痛、疼痛相关活动干扰和情绪的影响。具体目标1： 制定并手动实施22周处方阿片类药物减量支持干预，由护理经理在疼痛医学/精神病学医生和疼痛心理学家的监督和咨询下进行管理。这种干预将包括四个组成部分：a）参与视频和动机访谈干预; B）个性化，灵活的阿片类药物减量; c）疼痛自我管理培训; d）个人心理药理学咨询和计划。具体目标二：证明与常规阿片类药物处方治疗相比，在阿片类药物减量支持干预的RCT中招募和保留接受COT治疗CNCP的患者是可行的。具体目标3：获得关于本方法有效性的试验数据。 处方阿片类药物减量支持干预：a）在接受COT治疗CNCP的患者中实现持续的阿片类药物剂量减少，B）减少阿片类药物滥用和阿片类药物不良反应; c）改善患者疼痛、疼痛相关活动干扰和情绪。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，以评估支持处方阿片类药物减量干预在减少阿片类药物误用，滥用和过量方面的有效性。它还将表明这些目标是否可以在不显著恶化疼痛，情绪和活动的情况下实现。

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.