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

描述（申请人提供）：这项研究旨在解决临床困境，如何更有效，如果有的话，一个更新，更昂贵的形式纳洛酮（缓释纳洛酮，XR-NTX）与较旧的，更便宜的口服形式（O-NTX）相比，当用于简单的，基于初级护理的医疗管理方案时，并使用比较有效性，成本效益，实用的随机对照试验设计。在医疗之家、成瘾平等和医疗保险改革的时代，如果酒精障碍的治疗要有意义地扩大，初级保健医生和支付者必须相信有效、简单易用的药物治疗是值得开的。 本研究将包括一项实用的、随机的、开放标签的治疗试验，在初级保健中提供24周的XR-NTX与O-NTX医疗管理。将从社区招募N=234名> 18岁的酒精依赖成人，在曼哈顿下城的两个纽约市成人初级保健中心（Bellevue Hospital Center和Gouverneur Diagnostic and Treatment Center）进行治疗。主要结局将是在24周治疗试验的最后20周（第5-24周）期间戒酒或适度饮酒的良好临床结局。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。次要结果包括酒精摄入量的其他标准日历和计数测量（饮酒/天，戒酒天数，至第一个重度饮酒日的时间），作为连续变量的治疗保留，生物标志物包括GGT和CDT，以及mu阿片受体Asp 40功能等位基因状态与XR-NTX治疗有效性的相关性。

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.