Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

描述（由申请人提供）：处方阿片类药物依赖正在增加，并造成重大的公共卫生负担，但办公室医生缺乏基于证据的指南来决定是使用丁丙诺啡（Bup）维持治疗还是解毒治疗。尽管先前的研究已经证明维持对海洛因依赖患者的排毒有优势，但与海洛因依赖患者相比，处方阿片类药物依赖患者的良好临床特征和改善的治疗结果以及Bup戒断症状的严重程度降低使得许多医生推荐使用Bup对这些患者进行排毒。为了提供可用于制定处方阿片类药物依赖患者戒毒或维持治疗的循证指南的数据，拟议的研究在初级保健诊所的处方阿片类药物依赖患者（N=120）的异质人群中进行了为期18周的Bup随机临床试验，比较了Bup维持（Mtn）与解毒（Dtx）。患者在2周的诱导期后随机接受Mtn或Dtx治疗。Mtn旨在反映初级保健医生的常规护理，包括每周药物咨询（DC）和转介到辅助服务。随机化后的前4周Dtx和Mtn相同（稳定）。在Mtn中，Bup在研究的剩余时间内将保持不变。在Dtx中，Bup的剂量将在接下来的3周内逐渐减少到零，并且在研究的剩余时间内患者将不再接受额外的Bup。Dtx患者将在逐渐减少期间开始每周三次DC，纳曲酮将在最后一次Bup后7天提供。该研究将检验Mtn将导致非法药物使用减少的假设，并将证明与Dtx相比成本效益增加。对随机选取的患者意向治疗样本进行数据分析。主要结果包括减少非法阿片类药物的使用和戒断的实现，通过每周尿液毒理学测试和自我报告进行评估。次要结局包括患者保护性转移的比例、指定治疗的保留率、可卡因使用情况、艾滋病毒风险行为、患者满意度和健康状况。还将评价服务的利用情况和费用。与公共卫生相关：本研究的结果将有助于确定丁丙诺啡维持与解毒在初级保健处方阿片类药物依赖患者护理中的作用。

DESCRIPTION (provided by applicant): Prescription opioid dependence is increasing and creates a significant public health burden, but office-based physicians lack evidence-based guidelines to decide between maintenance or detoxification treatment with buprenorphine (Bup). Although prior research has demonstrated the superiority of maintenance over detoxification for heroin dependent patients, the favorable clinical characteristics and improved treatment outcomes for prescription opioid dependent patients compared to heroin dependent patients and decreased severity of withdrawal symptoms with Bup have led many physicians to recommend detoxification with Bup for these patients. To provide data that could be used to develop evidence-based guidelines regarding detoxification or maintenance treatment for prescription opioid dependent patients, the proposed study compares Bup maintenance (Mtn) vs. detoxification (Dtx) in a 18-week randomized clinical trial of Bup in a heterogeneous population of prescription opioid dependent patients (N=120) in a primary care clinic. Patients are randomized to Mtn or Dtx after a 2-week induction period. Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup. The study will test the hypothesis that Mtn will lead to decreased illicit drug use and will demonstrate incremental cost-effectiveness compared to Dtx. Data analyses will be conducted on the intention to treat sample of randomized patients. Primary outcomes include reductions in illicit opioid use and abstinence achievement, assessed by weekly urine toxicology testing and self report. Secondary outcomes include proportion of patients protectively transferred, retention in assigned treatment, cocaine use, HIV risk behaviors, patient satisfaction and health status. Utilization and costs of services will also be evaluated. Relevance to public health: The results of this study will help define the role of maintenance vs. detoxification with buprenorphine in the care of prescription opioid dependent patients in primary care.