口服美沙酮与舌下丁丙诺啡治疗急性阿片类药物戒断：一项三盲、双虚拟、随机对照试验

IF 3.6 2区医学 Q1 PSYCHIATRY

Drug and alcohol dependence Pub Date : 2025-07-12 DOI:10.1016/j.drugalcdep.2025.112793

Anil Shekhawat , Atul Ambekar , Alok Agrawal , Ravindra Venkat Rao , Ashwani Kumar Mishra , Arpit Parmar , Tathagata Biswas

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引用次数: 0

摘要

背景：类阿片使用障碍（OUD）是一个全球性的问题，其治疗涉及最初的辅助戒断，随后是维持阶段。美沙酮和丁丙诺啡是急性阿片类药物戒断管理（AOWM）最常用的药物，但它们的相对有效性仍不确定。本研究旨在比较口服美沙酮和舌下丁丙诺啡治疗住院AOWM的疗效和安全性。方法对2017-2019年印度新德里三级医疗中心收治的79例OUD患者（年龄18-60岁）进行随机双假人临床试验。参与者接受口服美沙酮(20mg /天；N = 40)或舌下丁丙诺啡(3.6 mg/天；N = 39)，在固定的时间表中允许从第4-10天逐渐减少。主要终点是治疗完成率，次要终点包括戒断严重程度（COWS、SOWS评分）、阿片类药物渴求（VAS）、额外药物使用和副作用。该研究是在机构伦理委员会（IEC）批准后进行的。结果两组在社会人口学和基线临床参数方面具有可比性。两组治疗完成率相似(丁丙诺啡：82%，美沙酮：82.5%；p = 0.95)。随着时间的推移，两种药物都显著减少了戒断症状和渴望，美沙酮显示出更大的戒断严重程度的降低(COWS， SOWS评分；p = 0.01)。两组间的副作用具有可比性。结论美沙酮与丁丙诺啡在急性阿片类药物戒断治疗完成率方面疗效相近。这些发现表明，美沙酮和丁丙诺啡可以作为住院患者急性阿片类药物戒断管理的有效和安全的选择。审判RegistrationCTRI / 2017/03/0079977

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Oral methadone versus sublingual buprenorphine for the treatment of acute opioid withdrawal: A triple-blind, double-dummy, randomized control trial

Background

Opioid use disorder (OUD) is a global problem with treatment involving an initial assisted withdrawal followed by maintenance phase. Methadone and buprenorphine are most commonly used agents for acute opioid withdrawal management (AOWM), but their comparative effectiveness remains uncertain. This study was aimed at comparing the efficacy and safety of oral methadone and sublingual buprenorphine for AOWM in in-patient setting.

Methods

A randomized double-dummy clinical trial was conducted with 79 patients (ages 18–60) admitted with OUD a tertiary-care center, New Delhi, India over three years (2017–2019). Participants received either oral methadone (20 mg/day; n = 40) or sublingual buprenorphine (3.6 mg/day; n = 39) in a fixed schedule allowing gradual tapering from day 4–10. The primary outcome was treatment completion rate, with secondary outcomes including withdrawal severity (COWS, SOWS scores), opioid craving (VAS), additional medication use, and side effects. The study was conducted after approval from the Institutional Ethics Committee (IEC).

Results

Both groups were comparable in terms of sociodemographic and baseline clinical parameters. Both groups had similar treatment completion rates (buprenorphine: 82 %, methadone: 82.5 %; p = 0.95). While both medications significantly reduced withdrawal symptoms and cravings over time, methadone showed greater reductions in withdrawal severity (COWS, SOWS scores; p = 0.01). Side effects were comparable between groups.

Conclusion

Methadone and buprenorphine demonstrated similar efficacy in treatment completion rates for acute opioid withdrawal. These findings suggest that methadone, alongside buprenorphine, can be an effective and safe option for acute opioid withdrawal management in inpatient settings.

Trial Registration

CTRI/2017/03/0079977

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来源期刊

Drug and alcohol dependence 医学-精神病学

CiteScore

7.40

自引率

7.10%

发文量

409

审稿时长

41 days

期刊介绍： Drug and Alcohol Dependence is an international journal devoted to publishing original research, scholarly reviews, commentaries, and policy analyses in the area of drug, alcohol and tobacco use and dependence. Articles range from studies of the chemistry of substances of abuse, their actions at molecular and cellular sites, in vitro and in vivo investigations of their biochemical, pharmacological and behavioural actions, laboratory-based and clinical research in humans, substance abuse treatment and prevention research, and studies employing methods from epidemiology, sociology, and economics.