Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence

丁丙诺啡和针对处方阿片类药物依赖的药物滥用服务

基本信息

批准号：
8927597
负责人：
CYNTHIA I CAMPBELL
金额：
$ 57.14万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-15 至 2018-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8927597
关键词：
Abstinence Address Adherence Admission activity Adoption Adult Affect Alcohol abuse Alcohol or Other Drugs use Behavior Therapy Behavioral Buprenorphine Caring Centers for Disease Control and Prevention (U.S.)Clinical Trials Network Communities Comorbidity Complex Computerized Medical Record Crime Data Dose Drug Formulations Drug abuse Emergency department visit Epidemic Health Health Information System Health Services Health system Healthcare High Prevalence Individual Influentials Inpatients Interview Knowledge Lead Mediating Medical Medication Management Modality Modeling Mono-S Naloxone National Institute of Drug Abuse Opiate Addiction Opioid Outcome Outpatients Overdose Patient Self-Report Patients Pharmaceutical Preparations Prevention Primary Health Care Psychosocial Assessment and Care Quality of life Randomized Recruitment Activity Relapse Reporting Research Risk Services Severities Societies Substance abuse problem Telephone Testing Treatment outcome Visit Work arm base behavioral clinical trial buprenorphine abuse compliance behavior cost cost effectiveness design disorder later incidence prevention dual diagnosis effective therapy follow-up health economics improved innovation medical specialties opioid abuse overdose death patient population prescription opioid randomized trial service intervention standard care tobacco abuse treatment effect treatment program

项目摘要

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.

描述（由申请人提供）：在美国，处方阿片类药物依赖影响着 190 万人，近年来治疗入院人数增加了 400%，每年有超过 15,500 例因用药过量而死亡。丁丙诺啡/纳洛酮 (BUP/NX) 是治疗处方阿片类药物依赖的有效方法，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。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) 结果所需的行为服务方面的知识差距。我们建议对 SU 专业治疗中的 BUP/NX 患者进行两种基于分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 依从性并改善结果，特别是对于患有医学和精神合并症并接受专业治疗的复杂患者。拟议的研究解决了这些重要问题，响应 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)”。该项目是一个大型门诊 SU 专业治疗项目，这些护理模式尚未在 BUP/NX 患者中进行过实证检验，并且治疗同时患有精神和医学合并症的患者的比例很高。 SSM 包括每周简短的小组就诊，与之前研究的医学模型一致，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，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 的成年患者，将他们随机分配到 SMM 或 IOT，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，我们将研究对于患有医学或精神合并症的患者来说，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在专科护理中重点关注患有精神科和医学合并症的复杂患者、采用以前仅在初级护理中测试的护理模式、12 个月的随访、没有研究强制的药物逐渐减少、对医疗保健的检查和社会成本，以及患者自我报告和电子病历数据的结合通过这种方法，拟议的研究将得出关于如何最好地治疗复杂处方阿片类药物依赖患者（不断增长的患者群体）的极其重要的发现。 SU 治疗中的综合行为服务和药物治疗模式。