Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence

描述(申请人提供)：处方阿片类药物依赖在美国影响着190万人，近年来治疗入院人数增加了400%，每年超过15,500人死亡过量。丁丙诺啡/纳洛酮(BUP/NX)是治疗处方阿片依赖的有效药物，坚持服药时间越长，阿片类药物复发的风险越低。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空白。我们建议在SU专科治疗中对两种基于组的BUP/NX患者的护理模式进行随机试验：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的坚持并改善结果，特别是对于患有内科和精神合并症的复杂患者，他们需要接受专门治疗。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)”。背景是一个大型的门诊SU专科治疗计划，在该计划中，这些护理模式尚未在BUP/NX患者中进行经验性测试，并对高患病率的精神疾病和内科并存患者进行治疗。SSM包括每周以小组为基础的简短访问，与之前研究的医疗模型一致，并来自初级保健BUP/NX研究。物联网是专科治疗中的一种主要护理模式，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名成年患者进入BUP/NX，随机将他们分配到SMM或IOT，并在6个月和12个月进行电话随访。我们将检查这些治疗方法对90天的BUP/NX依从性、阿片类药物的戒断和减少使用、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和SMM对内科或精神科合并症患者的依从性和SU治疗结果的影响是否更大。我们的创新方法包括在专科护理中关注患有精神疾病和医疗合并症的复杂患者，采用以前仅在初级保健中测试的护理模式，12个月的随访，无研究强制用药缩减，医疗保健和社会成本的检查，以及通过这种方法结合患者自我报告和电子病历数据，拟议的研究将产生关于如何最好地治疗复杂的处方阿片依赖患者的至关重要的发现，患者人数不断增长，并在SU治疗中采用整合的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.