Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care

初级保健中的缓释与口服纳曲酮酒精治疗

基本信息

批准号：
8703579
负责人：
JOSHUA D LEE
金额：
$ 130.06万
依托单位：
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-08-01 至 2018-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8703579
关键词：
Abstinence Address Adherence Adoption Adult Alcohol consumption Alcohol dependence Alcohols Alleles Behavior Therapy Biological Markers Calendar Caring Characteristics Clinic Clinical Clinical Trials Clinical Trials Design Clinical effectiveness Communities Comorbidity Cost Effectiveness Analysis Costs and Benefits Data Diagnostic Disease Effectiveness Evaluation FDA approved Factor Analysis Gender Genotype Head Health Insurance Health system Heavy Drinking Home environment Hospitals Injectable Intention Mainstreaming Measures Medicaid Medical Modeling Naltrexone National Institute on Alcohol Abuse and Alcoholism New York City Oral Outcome Participant Patients Persons Pharmaceutical Preparations Pharmacotherapy Primary Care Physician Primary Health Care Probability Protocols documentation Randomized Randomized Controlled Trials Recruitment Activity Relative (related person)Research Design Resource Allocation Site System Time TimeLine Treatment Effectiveness Treatment Protocols Uninsured Woman addiction alcohol abuse therapy arm base comparative effectiveness cost cost effective cost effectiveness drinking experience innovation medical specialties men mu opioid receptors novel open label parity patient oriented primary care setting primary outcome public health relevance secondary outcome systematic review treatment center treatment duration treatment trial

项目摘要

DESCRIPTION (provided by applicant): This study seeks to address the clinical dilemma of how much more effective, if any, a newer, more expensive form of naltrexone (Extended-Release Naltrexone, XR- NTX) is compared to the older, cheaper, oral form (O-NTX), when used in a simple, primary care-based, Medical Management protocol, and using a comparative effectiveness, cost-effectiveness, pragmatic randomized controlled trial design. If the treatment of alcohol disorders is to meaningfully expand in the era of the medical home, addiction parity, and health insurance reform, primary care physicians and payers must be convinced that effective, simple-to-use, pharmacotherapies are worth prescribing. This study will consist of a pragmatic, randomized, open-label treatment trial of 24 weeks of XR-NTX vs. O-NTX Medical Management delivered in primary care. N=234 adults >18yo with alcohol dependence will be recruited from the community to treatment at two New York City adult primary care sites in lower Manhattan, Bellevue Hospital Center and Gouverneur Diagnostic and Treatment Center. The primary outcome will be a good clinical outcome of abstinence or moderate drinking during the final 20 weeks (weeks 5-24) of a 24 week treatment trial. Cost effectiveness analysis will include long- term models of treatment impact on patient, health system, and societal costs. Secondary outcomes include other standard calendar and count measures of alcohol intake (drinks/day, days abstinent, time to first heavy drinking day), treatment retention as a continuous variable, biomarkers including GGT and CDT, and the association of mu opioid receptor Asp40 functional allele status with XR-NTX treatment effectiveness.

描述（由申请人提供）：本研究旨在解决临床难题，即一种更新、更昂贵的纳曲酮（缓释纳曲酮，XR-NTX）与旧的、更便宜的纳曲酮相比，效果如何（如果有的话）。口服形式（O-NTX），用于简单的、基于初级保健的医疗管理方案，并使用比较有效性、成本效益、务实的随机对照试验设计。如果要在医疗之家、成瘾平价和医疗保险改革时代有意义地扩大酒精障碍的治疗，初级保健医生和付款人必须相信有效、易于使用的药物疗法值得开出处方。这项研究将包括一项务实、随机、开放标签的治疗试验，在初级保健中进行 24 周的 XR-NTX 与 O-NTX 医疗管理治疗。将从社区招募 234 名 18 岁以上患有酒精依赖的成年人，前往位于曼哈顿下城的两个纽约市成人初级保健中心（贝尔维尤医院中心和 Gouverneur 诊断和治疗中心）接受治疗。主要结局将是在 24 周治疗试验的最后 20 周（第 5-24 周）内戒酒或适度饮酒的良好临床结果。成本效益分析将包括治疗对患者、卫生系统和社会成本影响的长期模型。次要结果包括其他标准日历和酒精摄入量的计数测量（饮酒/天、戒酒天数、到第一个大量饮酒日的时间）、作为连续变量的治疗保留、包括 GGT 和 CDT 在内的生物标志物，以及 mu 阿片受体 Asp40 功能的关联等位基因状态与 XR-NTX 治疗效果。