Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

处方阿片类药物依赖中的丁丙诺啡维持与戒毒

• 批准号: 7618749
• 负责人: David Fiellin
• 金额: $ 57.23万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-05 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7618749
• 关键词: Abstinence; Achievement; Agonist; Buprenorphine; Caring; Characteristics; Client satisfaction; Clinic; Clinical; Cocaine Abuse; Counseling; Coupled; Data; Data Analyses; Dose; Drug Metabolic Detoxication; Drug usage; Evidence based treatment; Guidelines; HIV; Health Status; Heroin; Illicit Drugs; Intention; Lead; Maintenance; Medical; Methadone; Naltrexone; Opiate Addiction; Opioid; Patient Self-Report; Patients; Pharmaceutical Preparations; Physical Dependence; Physicians; Population Heterogeneity; Primary Care Physician; Primary Health Care; Property; Public Health; Randomized; Randomized Clinical Trials; Relative (related person); Reporting; Research; Risk Behaviors; Role; Sampling; Services; Severities; Subgroup; Substance Withdrawal Syndrome; Surveys; Testing; Toxicology; Treatment outcome; Unemployment; Urine; Withdrawal; Withdrawal Symptom; base; cocaine use; cost; cost effectiveness; design; dosage; evidence based guidelines; experience; improved; male; methadone maintenance; opioid withdrawal; primary outcome; psychosocial; response; secondary outcome; social; treatment as usual

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.

描述（由申请人提供）：处方阿片类药物依赖性正在增加，并造成了巨大的公共健康负担，但是基于办公室的医生缺乏基于证据的指南，无法在用丁丙诺啡（BUP）进行维护或排毒治疗之间做出决定。尽管与海洛因依赖性患者相比，先前的研究表明，与海洛因依赖性患者相比，维持依赖海洛因的患者的维持优于海洛因依赖性患者的排毒优势，但与海洛因依赖性患者相比，临床特征改善了治疗结果，并降低了bup的戒断症状的严重性降低，导致许多医生推荐这些患者的BUP解毒。为了提供可用于制定有关处方阿片类依赖性患者排毒或维持治疗的基于证据的指南，拟议的研究比较了在异构处方依赖患者（n = 1200）中，在一项为18周的bup中比较了bup的18周随机临床试验中的BUP维护（MTN）与排毒（DTX）。 2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常规护理，包括每周药物咨询（DC）和转介辅助服务。随机分组后的前4周（稳定），DTX和MTN将相同。在MTN中，BUP将在其余的研究中继续保持不变。在DTX中，在接下来的3周内，BUP的剂量将逐渐缩小到零，并且该研究的其余部分将不会获得额外的BUP。在锥度期间，将提供三次DTX患者，并在最后剂量BUP后7天提供Naltrexone。该研究将检验以下假设：MTN将导致非法药物使用降低，并且与DTX相比将证明成本效益增长。数据分析将针对治疗随机患者的样本进行。主要结果包括通过每周尿液毒理学测试和自我报告评估非法阿片类药物使用和戒酒成就的减少。次要结果包括保护性转移的患者比例，在指定的治疗中保留，可卡因使用，艾滋病毒风险行为，患者满意度和健康状况。还将评估使用和服务成本。与公共卫生的相关性：这项研究的结果将有助于定义维护与用丁丙诺啡排毒的作用，以在初级保健中照顾处方阿片类药物依赖性患者。