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，并造成严重的公共卫生负担，但办公室医生缺乏循证指南来决定是维持还是使用丁丙诺啡(Bup)戒毒治疗。尽管先前的研究已经证明了海洛因依赖患者维持戒毒的优越性，但与海洛因依赖患者相比，处方阿片依赖患者良好的临床特征和改善的治疗结果，以及使用Bup减轻戒断症状的严重程度，导致许多医生建议这些患者使用Bup戒毒。为了提供可用于制定处方阿片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不同人群(N=120)的处方阿片依赖患者(N=120)中进行了为期18周的Bup随机临床试验，比较了Bup维持(MTN)和戒毒(DTX)。在两周的诱导期后，患者被随机分为MTN或DTX。MTN旨在反映初级保健医生的日常护理，包括每周药物咨询(DC)和转介到辅助服务。DTX和MTN在随机化后的前4周(稳定)是相同的。在MTN中，Bup在研究的其余部分将继续保持不变。在DTX中，Bup的剂量将在接下来的3周内逐渐减少到零，在剩下的研究中，患者将不再接受额外的Bup。DTX患者将从缩减期间开始每周服用三次DC，纳曲酮将在最后一剂Bup后7天提供。这项研究将检验这样一种假设，即MTN将导致非法药物使用的减少，并将证明与DTX相比具有递增的成本效益。将对随机抽样患者的治疗意向进行数据分析。主要结果包括通过每周尿毒学检测和自我报告评估非法阿片类药物使用和戒断成就的减少。次要结果包括保护性转移患者的比例、保留分配的治疗、可卡因使用、艾滋病毒危险行为、患者满意度和健康状况。还将评估服务的利用率和成本。与公共健康的相关性：这项研究的结果将有助于确定维持与丁丙诺啡戒毒在初级保健中处方阿片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.