Counseling for Primary Care Office-Based Buprenorphine

描述(由申请人提供)： 丁丙诺啡(Bup)作为治疗阿片类药物依赖的疗效已经在包括现场药物咨询在内的试验中得到证实。为了扩大治疗阿片类药物依赖的机会，新的规定使Bup可以在初级保健中使用，而不需要义务咨询。尽管有证据表明，在阿片类药物治疗计划中，当药物咨询与美沙酮治疗一起提供时，结果会有所改善，但在初级保健中，没有这样的证据支持Bup治疗。新出现的证据表明，由于财政、后勤和能力的限制，提供Bup治疗的PCC医生可能会提供与联邦法规最低要求一致的低水平咨询服务。我们在初级保健中对Bup的研究表明了现场药物咨询的可行性；Bup依从性的巨大变异性以及改善Bup依从性与改善结果之间的强烈关联；早期禁欲的重要性和脆弱性；以及即使在最初的6个月内实现持续戒毒的患者也经常在6个月内复发。为了评估旨在减少非法药物使用和增加Bup依从性的药物咨询的必要性，拟议的研究比较了手动指导的医生管理(PM)和PM与现场手动指导的认知行为治疗(CBT)相结合的Bup在初级保健诊所的异类阿片依赖患者(N=140)中的24周随机临床试验。PM与联邦法规一致，旨在反映初级保健医生的日常护理，并包括转诊至辅助服务。CBT将由熟练的心理学家在头12周的每周会议上提供，重点是减少非法药物使用和增加Bup的依从性。这项研究将检验这样一种假设，即在PM中加入CBT将减少非法药物的使用，在停止咨询后产生持久的效果，改善Bup的依从性，并将证明在初级保健中接受Bup维护的患者具有递增的成本效益。主要结果措施包括减少非法阿片类药物的使用和戒断成就，通过每周尿毒学测试和自我报告进行评估。次要结果措施包括保留治疗、减少可卡因使用和艾滋病毒风险、减少犯罪活动以及改善健康和就业状况。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好处和问题的看法。这项研究的结果将有助于确定专业的循证药物咨询在扩大BUP治疗途径方面的作用。

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.