New York University School of Medicine, Department of Population Health, United States of America.
New York University School of Medicine, Department of Population Health, United States of America; New York University School of Medicine, Department of Medicine, United States of America.
Contemp Clin Trials. 2019 Jun;81:102-109. doi: 10.1016/j.cct.2019.04.006. Epub 2019 Apr 12.
Extended-release naltrexone (XR-NTX, Vivitrol®) and daily oral naltrexone tablets (O-NTX) are FDA-approved mu opioid receptor antagonist medications for alcohol dependence treatment. Despite the efficacy of O-NTX, non-adherence and poor treatment retention have limited its adoption into primary care. XR-NTX is a once-a-month injectable formulation that offers a potentially more effective treatment option in reducing alcohol consumption and heavy drinking episodes among persons with alcohol use disorders.
This pragmatic, open-label, randomized controlled trial examines the effectiveness of XR-NTX vs. O-NTX in producing a Good Clinical Outcome, defined as abstinence or moderate drinking (<2 drinks/day, men; <1 drink/day, women; and < 2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management treatment for alcohol dependence. Secondary aims will estimate the cost effectiveness of XR-NTX vs. O-NTX, in conjunction with primary-care based Medical Management for both groups, and patient-level characteristics associated with effectiveness in both arms. Alcohol dependent persons are recruited from the community into treatment in a New York City public hospital primary care setting (Bellevue Hospital Center) for 24 weeks of either XR-NTX (n = 117) or O-NTX (n = 120).
We describe the rationale, specific aims, design, and recruitment results to date. Alternative design considerations and secondary aims and outcomes are reported.
XR-NTX treatment in a primary care setting is potentially more efficacious, feasible, and cost-effective than oral naltrexone when treating community-dwelling persons with alcohol use disorders. This study will estimate XR-NTX's treatment and cost effectiveness relative to oral naltrexone.
缓释纳曲酮（XR-NTX，Vivitrol®）和每日口服纳曲酮片剂（O-NTX）是经美国食品药品监督管理局批准的用于治疗酒精依赖的μ阿片受体拮抗剂药物。尽管 O-NTX 有效，但由于不依从和治疗保留率低，其在初级保健中的应用受到限制。XR-NTX 是一种每月一次的注射制剂，为减少有酒精使用障碍的人饮酒和重度饮酒发作提供了一种潜在更有效的治疗选择。
这项实用、开放标签、随机对照试验研究了 XR-NTX 与 O-NTX 在产生良好临床结果方面的有效性，良好临床结果定义为在基于初级保健的医学管理治疗的最后 20 周中（24 周），酒精依赖患者达到戒酒或适度饮酒（男性<2 饮料/天，女性<1 饮料/天，每月<2 次重度饮酒）。次要目标将评估 XR-NTX 与 O-NTX 的成本效益，同时评估两组基于初级保健的医学管理的成本效益，以及与两组疗效相关的患者特征。在纽约市一家公立医院初级保健环境（Bellevue 医院中心）中，从社区招募酒精依赖者，进行 24 周的 XR-NTX（n=117）或 O-NTX（n=120）治疗。
我们描述了目前的基本原理、具体目标、设计和招募结果。还报告了替代设计考虑因素和次要目标及结果。
在初级保健环境中，与口服纳曲酮相比，XR-NTX 治疗对社区居住的酒精使用障碍患者可能更有效、更可行且更具成本效益。这项研究将估计 XR-NTX 相对于口服纳曲酮的治疗和成本效益。
