Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence

描述（由申请人提供）：处方阿片类药物依赖影响了美国190万人，近年来治疗入院人数增加了400%，每年有超过15,500人因过量服用而死亡。丁丙诺啡/纳洛酮（BUP/NX）是处方阿片类药物依赖的有效治疗方法，长期坚持用药可降低阿片类药物复发的风险。然而，依从性可能很低，行为服务仍然是治疗的关键部分。本研究解决了在处方阿片类药物依赖治疗中优化BUP/NX依从性和物质使用（SU）结果所需的行为服务方面的知识差距。我们建议在SU专科治疗中对BUP/NX患者进行两种基于组的护理模式的随机试验：标准医疗管理（SMM）和强化门诊治疗（IOT）。很少有证据表明什么水平的行为服务可以支持BUP/NX依从性并改善结果，特别是对于那些有医学和精神合并症的复杂患者，他们正在接受专科治疗。拟议的研究解决了这些重要问题，回应了PA-12-237，“预防和治疗药物、酒精和烟草滥用的卫生服务和经济研究（R01）”。该研究的背景是一个大型门诊SU专科治疗项目，这些护理模式尚未在BUP/NX患者中进行经验检验，并且在这里治疗的患者中同时出现精神和医学合并症的比例很高。SSM包括与先前研究的医学模型一致的每周简短的小组访问，并从初级保健BUP/NX研究中提取。物联网是专科治疗中的主要护理模式，它结合了社会心理支持、12步治疗、教育和预防复发的方法。我们将招募600名入选BUP/NX的成年患者，随机分为SMM组和IOT组，分别在6个月和12个月进行电话随访。我们将研究这些治疗方法对90天BUP/NX依从性、阿片类药物戒断和减少使用、其他SU、生活质量、医疗保健和社会成本的影响。此外，我们将研究对于那些患有医学或精神合并症的患者，IOT与SMM对依从性和SU治疗结果的影响是否更大。我们的创新方法包括专注于专业护理中患有精神和医学合并症的复杂患者，采用以前仅在初级保健中测试过的护理模式，进行12个月的随访，无研究强制减量用药，检查医疗保健和社会成本，并结合患者自我报告和电子病历数据。拟议的研究将在如何最好地治疗复杂的处方阿片类药物依赖患者方面产生至关重要的发现，这是一个不断增长的患者群体，在SU治疗中采用综合行为服务和药物治疗模式。

DESCRIPTION (provided by applicant): Prescription opioid dependence affects 1.9 million in the U.S, with a 400% increase in treatment admissions in recent years, and more than 15,500 fatal overdoses a year. Buprenorphine/naloxone (BUP/NX) is an effective treatment for prescription opioid dependence, with longer adherence to the medication leading to a lower risk of opioid relapse. Yet adherence can be low, and behavioral services remain a critical part of treatment. This study addresses gaps in knowledge about the behavioral services needed to optimize BUP/NX adherence and substance use (SU) outcomes in the treatment of prescription opioid dependence. We propose a randomized trial of two group-based models of care for BUP/NX patients in SU specialty treatment: Standard Medical Management (SMM) and Intensive Outpatient Treatment (IOT). There is little evidence on what level of behavioral services can support BUP/NX adherence and improve outcomes, particularly for complex patients with medical and psychiatric comorbidities who present to specialty treatment. The proposed study addresses these important issues, responding to PA-12-237, "Health Services and Economic Research on the Prevention and Treatment of Drug, Alcohol, and Tobacco Abuse (R01)." The setting is a large outpatient SU specialty treatment program, where these models of care have not been empirically tested with BUP/NX patients, and where a high prevalence of patients with co-occurring psychiatric and medical comorbidities are treated. SSM includes brief weekly group-based visits consistent with previously studied medical models, and is drawn from primary care BUP/NX research. IOT is a predominant model of care in specialty treatment, and incorporates psychosocial support, 12-step, educational and relapse-prevention based approaches. We will recruit 600 adult patients inducted onto BUP/NX, randomize them to either SMM or IOT, and conduct telephone follow-up interviews at 6 and 12 months. We will examine the impact of these treatment approaches on 90-day BUP/NX adherence, opioid abstinence and reductions in use, other SU, quality of life, and health care and societal costs. Further, we will examine whether the effect of IOT versus SMM on adherence and SU treatment outcomes is greater for those with medical or psychiatric comorbidities. Our innovative approach includes a focus on complex patients with psychiatric and medical comorbidities in specialty care, adapting a care model previously only tested in primary care, a 12-month follow-up, no research-forced medication taper, an examination of health care and societal costs, and a combination of patient self-report and electronic medical record data Through this approach, the proposed study will yield critically important findings on how best to treat complex prescription opioid dependent patients, a growing patient population, with an integrative behavioral services and medication treatment model in SU treatment.