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。意外过量服用处方类阿片是意外死亡增长最快的原因，在8个州超过了机动车事故。这些趋势与慢性非癌性疼痛（CNCP）的慢性阿片类药物治疗（COT）的使用增加并行，目前估计有1000万接受者或3%的美国人口。处方类阿片暴露会以剂量和持续时间依赖的方式增加滥用和过量的风险。目前尚不清楚4个月以上的COT是否真的能改善疼痛、情绪或功能。处方类阿片暴露会以剂量和持续时间依赖的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，而不会显著恶化疼痛、情绪和功能。然而，在CNCP治疗的患者中，没有COT逐渐减少的方案被测试过。研究目标：拟开展的研究将开发、论证处方阿片类药物减少支持干预的可行性，并在随机对照试验中进行试点试验。该干预措施旨在防止在没有药物滥用证据的CNCP患者中接受COT的阿片类药物滥用和不良事件。该项目将为规划未来更大规模的随机对照试验提供必要的信息，旨在评估干预措施在预防处方阿片类药物滥用、误用、过量和其他不良事件方面的效果，并评估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:To

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.