Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence

处方阿片类药物依赖影响美国190万人，近年来治疗入院人数增加了400%，每年有超过15，500例致命过量。丁丙诺啡/纳洛酮（BUP/NX）是一种有效的治疗处方阿片类药物依赖的药物，更长时间的坚持用药导致阿片类药物复发的风险较低。然而，依从性可能很低，行为服务仍然是治疗的关键部分。这项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）结局所需的行为服务方面的知识差距。我们提出了一项对SU专科治疗中BUP/NX患者的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）。几乎没有证据表明什么水平的行为服务可以支持BUP/NX的依从性并改善结局，特别是对于患有医学和精神科共病的复杂患者，他们需要接受专业治疗。拟议的研究针对这些重要问题，回应PA-12-237，“关于预防和治疗药物、酒精和烟草滥用的卫生服务和经济研究（R 01）。“该设置是一个大型的门诊SU专业治疗计划，其中这些护理模式尚未在BUP/NX患者中进行经验性测试，并且患有精神和医学共病的患者的患病率很高。SSM包括与先前研究的医学模型一致的每周简短的基于组的访问，并且来自初级保健BUP/NX研究。IOT是专业治疗中的主要护理模式，并结合了心理社会支持，12步，教育和预防复发的方法。我们将招募600名接受BUP/NX治疗的成年患者，将其随机分配至SMM或IOT组，并在6个月和12个月时进行电话随访。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、生活质量以及医疗保健和社会成本的影响。此外，我们将研究IOT与SMM对依从性和SU治疗结局的影响是否对患有医学或精神病合并症的患者更大。我们的创新方法包括专注于专科护理中患有精神和医学共病的复杂患者，采用以前仅在初级护理中测试的护理模式，12个月的随访，无研究强制药物减量，检查医疗保健和社会成本，以及患者自我报告和电子病历数据的组合。这项研究将产生至关重要的发现，如何最好地治疗复杂的处方阿片类药物依赖患者，不断增长的患者群体，与综合行为服务和药物治疗模式在SU治疗。

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.