Counseling for Primary Care Office-Based Buprenorphine

初级保健办公室丁丙诺啡咨询

• 批准号: 7113846
• 负责人: David Fiellin
• 金额: $ 57.73万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-20 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7113846
• 关键词: behavioral /social science research tag; buprenorphine; clinical research; clinical trials; cocaine; cognitive behavior therapy; combination therapy; cost effectiveness; counseling; criminal behavior; drug /alcohol abstinence; drug abuse chemotherapy; drug addiction; drug detection; employment /unemployment; health care service evaluation; high risk behavior /lifestyle; human subject; human therapy evaluation; opiate alkaloid; outcomes research; patient care management; relapse /recurrence; therapy compliance; urinalysis

DESCRIPTION (provided by applicant): The efficacy of Buprenorphine (Bup) as a treatment for opioid dependence has been established in trials that included on-site drug counseling. In an effort to expand access to treatment for opioid dependence, new regulations make Bup available in primary care without obligate counseling. Despite evidence demonstrating improved outcomes when drug counseling is provided along with methadone treatment in opioid treatment programs, no such evidence exists for Bup treatment in primary care. Emerging evidence indicates that PCC physicians offering Bup treatment will likely provide a low level of counseling services, consistent with the minimum requirements under federal regulations, due to fiscal, logistical and competency constraints. Our studies of Bup in primary care demonstrate the feasibility of on-site drug counseling; great variability in Bup adherence and a strong association between improved Bup adherence and improved outcomes; the importance and fragility of early abstinence; and frequent relapse within 6 months even among patients who achieve sustained abstinence during initial 6 months of treatment. To evaluate the need for drug counseling aimed at reducing illicit drug use and increasing Bup adherence, the proposed study compares manual-guided Physician Management (PM) and PM combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) in a 24 week randomized clinical trial of Bup in a heterogeneous population of opioid dependent patients (N=140) in a primary care clinic. PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services. CBT will be provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing Bup adherence. The study will test the hypothesis that that the addition of CBT to PM will lead to decreased illicit drug use, durable effects after counseling has been discontinued, improved Bup adherence and will demonstrate incremental cost-effectiveness in patients receiving Bup maintenance in primary care. Primary outcome measures include reductions in illicit opioid use and abstinence achievement, as assessed by weekly urine toxicology testing and self report. Secondary outcome measures include retention in treatment, reductions in cocaine use and HIV risk, decreased criminal activity and improved health and employment status. Utilization and costs of services, spillover effects in the PCC, and patient and staff perceptions of benefits and problems associated with primary care agonist maintenance treatment will also be evaluated. The results of this study will help define the role of professional evidence-based drug counseling in expanding access to treatment with Bup.

描述（由申请人提供）： 丁丙诺啡（BUP）作为阿片类药物依赖的治疗方法的功效已在包括现场药物咨询的试验中建立。为了扩大阿片类药物依赖的治疗机会，新法规使BUP在初级保健中可用，而无需咨询。尽管有证据表明在阿片类药物治疗计划中提供药物咨询以及美沙酮治疗时的结果有所改善，但在初级保健中尚无这种证据。新兴证据表明，提供BUP治疗的PCC医生可能会提供低水平的咨询服务，这与联邦法规下的最低要求，这是由于财政，后勤和能力限制。我们对初级保健中BUP的研究证明了现场药物咨询的可行性； bup依从性的巨大差异和改善的烟囱依从性与改善结果之间的牢固关联；早期禁欲的重要性和脆弱性；甚至在治疗最初6个月内实现持续戒酒的患者中，甚至在6个月内频繁复发。为了评估旨在减少非法药物使用并增加bup依从性的药物咨询的需求，拟议的研究比较了手动引导的医师管理（PM）和PM与现场手动指导的认知行为疗法（CBT）相结合在初级保健诊所中，bup的随机临床试验（n = 140）在异质群中的随机临床试验。与联邦法规一致的PM旨在反映初级保健医师的常规护理，并包括转介辅助服务。 CBT将由熟练的心理学家在最初的12周内在每周一次的会议上提供，并着重于减少非法吸毒并增加bup依从性。这项研究将检验以下假设：在PM中添加CBT将导致非法药物使用降低，咨询后持续的效果已停止，bup依从性提高，并且会在接受初级保健中接受BUP维持的患者中表现出渐进的成本效益。主要结局指标包括减少非法阿片类药物使用和戒酒成就，如每周尿毒理学测试和自我报告所评估。次要结果措施包括保留治疗，可卡因使用的减少和艾滋病毒风险，犯罪活动减少以及改善健康和就业状况。还将评估服务和服务成本，PCC的溢出效应以及患者和员工对与初级保健激动剂维护治疗相关的福利和问题的看法。这项研究的结果将有助于定义专业循证药物咨询在扩大BUP接受治疗方面的作用。