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：
9114551
负责人：
CYNTHIA I CAMPBELL
金额：
$ 60.09万
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/9114551
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 abuse Emergency department visit Epidemic Formulation 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 improved outcome innovation medical specialties opioid abuse opioid use 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）：处方阿片类药物依赖性在美国影响190万，近年来治疗入院增加了400％，每年超过15,500次致命过量服用。丁丙诺啡/纳洛酮（BUP/NX）是处方阿片类药物依赖性的有效治疗方法，对药物的依从性更长，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。这项研究解决了有关优化bup/nx依从性和药物使用（SU）结果所需的行为服务的知识差距（SU）。我们建议对SU专业治疗中的BUP/NX患者进行两种基于组的护理模型的随机试验：标准医疗管理（SMM）和强化门诊治疗（IOT）。几乎没有证据表明哪种行为服务可以支持BUP/NX依从性并改善结果，特别是对于患有专业治疗的医学和精神病患者的复杂患者。拟议的研究解决了这些重要问题，对PA-12-237的回应，“关于预防和治疗毒品，酒精和烟草滥用的卫生服务和经济研究（R01）”。该环境是一个大型门诊SU专业治疗计划，在该计划中尚未对BUP/NX患者进行经验测试，并且患有同时发生的精神病和医学合并症患者的患病率很高。 SSM包括与先前研究的医学模型一致的简短每周基于小组的访问，并根据初级保健BUP/NX研究得出。物联网是专业治疗中的主要护理模型，并结合了社会心理支持，12步，基于教育和预防复发的方法。我们将招募600名成年患者，将其引入BUP/NX，将其随机为SMM或IoT，并在6个月和12个月时进行电话后续访谈。我们将研究这些治疗方法对90天BUP/NX依从性，阿片类药物的禁欲和减少，其他SU，生活质量以及医疗保健和社会成本的影响。此外，我们将研究物联网与SMM对依从性和SU治疗结果的影响是否对于患有医学或精神病患者的人的影响更大。 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在SU治疗中具有综合行为服务和药物治疗模型，患者人群不断增长。