Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care (XON).
Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care (XON).
复制标题
初级保健中酒精依赖治疗的缓释剂与口服纳曲酮 (XON)。
DOI：
10.1016/j.cct.2019.04.006
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发表时间：
2019
影响因子：
2.2
通讯作者：
Lee,JoshuaD
中科院分区：
文献类型：
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作者：
Malone,Mia;McDonald,Ryan;Vittitow,Alex;Chen,Jenny;Obi,Rita;Schatz,Daniel;Tofighi,Babak;Garment,Ann;Kermack,Andrea;Goldfeld,Keith;Gold,Heather;Laska,Eugene;Rotrosen,John;Lee,JoshuaD
背景缓释纳曲酮（XR-NTX、Vivitrol®）和每日口服纳曲酮片（O-NTX）是 FDA 批准的用于治疗酒精依赖的 mu 阿片受体拮抗剂药物。尽管 O-NTX 有效，但不依从性和治疗保留率差限制了其在初级保健中的采用。 XR-NTX 是一种每月一次的注射制剂，为减少酒精使用障碍患者的饮酒量和酗酒事件提供了潜在更有效的治疗选择。方法这项务实、开放标签、随机对照试验检查了 XR-NTX 与 O-NTX 在产生良好临床结果方面的有效性，良好的临床结果定义为戒酒或适度饮酒（<2 杯/天， 男人； <1 杯/天，女性；在针对酒精依赖的初级保健医疗管理治疗的 24 周的最后 20 周内，饮酒次数<2 次/月）。次要目标将评估 XR-NTX 与 O-NTX 的成本效益，结合两组基于初级保健的医疗管理，以及与两组有效性相关的患者水平特征。从社区招募酒精依赖者在纽约市公立医院初级保健机构（贝尔维尤医院中心）接受为期 24 周的 XR-NTX (n=117) 或 O-NTX (n=120) 治疗。结果我们描述了迄今为止的基本原理、具体目标、设计和招募结果。报告了替代设计考虑因素以及次要目标和结果。结论在治疗患有酒精使用障碍的社区居民时，初级保健机构中的 XR-NTX 治疗可能比口服纳曲酮更有效、更可行且更具成本效益。这项研究将评估 XR-NTX 相对于口服纳曲酮的治疗和成本效益。
BackgroundExtended-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.MethodsThis 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).ResultsWe describe the rationale, specific aims, design, and recruitment results to date. Alternative design considerations and secondary aims and outcomes are reported.ConclusionsXR-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.