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

• 批准号: 8614727
• 负责人: CYNTHIA I CAMPBELL
• 金额: $ 54.39万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 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/8614727
• 关键词: Abstinence; Accident and Emergency department; 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; 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; public health relevance; randomized trial; service intervention; standard care; tobacco abuse; treatment effect; treatment program

ABSTRACT 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.

摘要 处方阿片类药物依赖影响美国190万人，治疗增加400% 近年来的入院人数，以及每年超过15,500人的致命过量。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，坚持服药时间更长 以降低阿片类药物复发的风险。然而，遵从性可能很低，行为服务仍然是 治疗。这项研究解决了优化BUP/NX所需的行为服务方面的知识空白 处方阿片依赖治疗中的依从性和物质使用(SU)结果。我们提出了一个 SU专科治疗中两组BUP/NX患者护理模式的随机试验：标准 医疗管理(SMM)和强化门诊治疗(IOT)。几乎没有证据表明这一水平 的行为服务可以支持遵守BUP/NX并改善结果，特别是对于复杂的 患有内科和精神科合并症的患者，需要接受专科治疗。建议进行的研究 解决这些重要问题，回应PA-12-237，“卫生服务和经济研究 预防和治疗药物、酒精和烟草滥用(R01)。设置是一个大型门诊苏 专业治疗计划，其中这些护理模式尚未经过BUP/NX的经验测试 患者，以及精神疾病和内科并存患者的高患病率 治疗过了。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，以及 来自初级保健BUP/NX研究。物联网是专科治疗中的主要护理模式， 包括心理社会支持、12步、教育和基于预防复发的方法。我们会 招募600名成年患者进入BUP/NX，将他们随机分配到SMM或IOT，并进行 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的影响。 关于90天的BUP/NX依从性、阿片类药物的戒断和减少使用、其他SU、生活质量和健康 护理和社会成本。进一步，我们将检验物联网和SMM对依从性和SU的影响 对于那些患有内科或精神共病的人来说，治疗结果更好。我们的创新方法 包括重点关注在专科护理中患有精神疾病和医疗并发症的复杂患者，适应 以前只在初级保健中测试的护理模式，12个月的随访，没有研究强迫用药缩减， 对医疗保健和社会成本的检查，以及患者自我报告和电子邮件的结合 通过这种方法，拟议的研究将在以下方面产生至关重要的发现： 最好治疗复杂的处方阿片类药物依赖患者，患者数量不断增长，具有综合性 SU治疗中的行为服务和药物治疗模式。