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

描述(由申请人提供)：这项研究试图解决临床两难境地，即当在简单的、以初级保健为基础的医疗管理方案中使用时，使用比较有效性、成本效益、务实的随机对照试验设计时，较新的、更昂贵的纳曲酮形式(缓释纳曲酮，XR-NTX)与较旧的、更便宜的口服形式(O-NTX)相比要有效得多，如果有的话。如果酒精障碍的治疗要在医疗院、成瘾平价和医疗保险改革的时代有意义地扩大，初级保健医生和付款人必须相信，有效、简单易用的药物疗法值得开出处方。这项研究将包括一项务实的、随机的、开放标签的治疗试验，试验对象是24周的XR-NTX与O-NTX在初级保健中提供的医疗管理。N=234名有酒精依赖的成年人将从社区招募到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古弗内尔诊断和治疗中心接受治疗。主要结果将是在24周治疗试验的最后20周(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。次要结果包括酒精摄入量的其他标准日历和计数指标(饮酒量/天、戒酒天数、第一次大量饮酒的时间)、作为连续变量的治疗保留、包括GGT和CDT在内的生物标记物，以及MU阿片受体Asp40功能等位基因状态与XR-NTX治疗效果的关联。

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.