Counseling for Primary Care Office-Based Buprenorphine

描述（由申请人提供）： 丁丙诺啡（Bup）作为阿片类药物依赖治疗的疗效已在包括现场药物咨询的试验中确立。为了扩大阿片类药物依赖治疗的可及性，新法规使Bup在初级保健中可用，而无需强制咨询。尽管有证据表明，在阿片类药物治疗计划中，药物咨询与美沙酮治疗一起提供沿着时，结果有所改善，但在初级保健中不存在Bup治疗的证据。新出现的证据表明，PCC医生提供Bup治疗可能会提供低水平的咨询服务，符合联邦法规下的最低要求，由于财政，后勤和能力的限制。我们对Bup在初级保健中的研究表明了现场药物咨询的可行性; Bup依从性的巨大差异以及改善Bup依从性和改善结局之间的强相关性;早期禁欲的重要性和脆弱性;以及即使在最初6个月治疗期间实现持续禁欲的患者中，6个月内也会频繁复发。为了评估旨在减少非法药物使用和增加Bup依从性的药物咨询需求，拟议的研究在初级保健诊所的阿片类药物依赖患者（N=140）的异质人群中进行了一项为期24周的Bup随机临床试验，比较了手动指导的医生管理（PM）和PM结合现场手动指导的认知行为治疗（CBT）。PM符合联邦法规，旨在反映初级保健医生的常规护理，包括转诊到辅助服务。CBT将由熟练的心理学家在前12周每周提供一次，重点是减少非法药物的使用和增加Bup的依从性。该研究将检验一个假设，即在PM中加入CBT将导致非法药物使用减少，咨询停止后的持久效果，改善Bup依从性，并将证明在初级保健中接受Bup维持治疗的患者的成本效益增加。主要结果指标包括减少非法阿片类药物的使用和禁欲的成就，通过每周尿液毒理学检测和自我报告进行评估。次要结果指标包括继续治疗、可卡因使用和艾滋病毒风险减少、犯罪活动减少以及健康和就业状况改善。还将评估服务的利用率和成本、PCC的溢出效应以及患者和工作人员对与初级保健激动剂维持治疗相关的益处和问题的看法。这项研究的结果将有助于确定专业循证药物咨询在扩大Bup治疗中的作用。

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.