Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville).
Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville).
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DOI：
10.1371/journal.pone.0112328
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Methaville Study Group
中科院分区：
文献类型：
--
作者：
Carrieri PM;Michel L;Lions C;Cohen J;Vray M;Mora M;Marcellin F;Spire B;Morel A;Roux P;Methaville Study Group
许多国家的美沙酮覆盖率很低，部分原因是美沙酮诱导只能在专门护理 (SC) 中进行。这项多中心实用试验比较了两种诱导模式（初级保健 (PC) 和 SC）之间美沙酮治疗的有效性。在这项在 ClinicalTrials.Gov (NCT00657397) 注册的研究中，未接受美沙酮治疗至少一个月或未接受丁丙诺啡但需要转换的阿片类药物依赖个体被随机分配到法国 10 个地点的 PC 组 (N = 155) 或 SC (N = 66) 中开始使用美沙酮。访问安排在 M0、M3、M6 和 M12 月份。主要结局是自我报告在 12 个月 (M12) 时戒除街头阿片类药物（PC 的潜在 15% 非劣效性假设）。次要结局是随访期间的禁欲、参与治疗（即完成诱导期）、对医生提供的解释的保留和满意度。主要分析使用意向治疗（ITT）。混合模型和对数秩检验分别用于评估戒断和保留过程中的手臂效应（PC 与 SC）。 ITT 分析（PC 中 n = 155，SC 中 66）比较了街头阿片类药物戒断参与者的比例，在 PC 和 SC 中，M12 时分别有 85/155 (55%) 和 22/66 (33%) 的参与者被归类为街头阿片类药物戒断者。该 ITT 分析显示 PC 的非劣效性 (21.5 [7.7; 35.3])。 PC 中的治疗参与度和对医生提供的解释的满意度显着高于 SC。随访期间美沙酮的保留率和戒断率在两组中相当（分别为 p = 0.47，p = 0.39）。在适当的条件下，初级保健中的美沙酮诱导治疗是可行的，并且为医生和患者所接受。它与专门护理的诱导一样有效，可以减少街头阿片类药物的使用，并确保参与和保留阿片类药物依赖的治疗。编号Eudact 2008-001338-28； ClinicalTrials.gov：NCT00657397；国际标准随机对照试验编号寄存器ISRCTN31125511
Methadone coverage is poor in many countries due in part to methadone induction being possible only in specialized care (SC). This multicenter pragmatic trial compared the effectiveness of methadone treatment between two induction models: primary care (PC) and SC. In this study, registered at ClinicalTrials.Gov (NCT00657397), opioid-dependent individuals not on methadone treatment for at least one month or receiving buprenorphine but needing to switch were randomly assigned to start methadone in PC (N = 155) or in SC (N = 66) in 10 sites in France. Visits were scheduled at months M0, M3, M6 and M12. The primary outcome was self-reported abstinence from street-opioids at 12 months (M12) (with an underlying 15% non-inferiority hypothesis for PC). Secondary outcomes were abstinence during follow-up, engagement in treatment (i.e. completing the induction period), retention and satisfaction with the explanations provided by the physician. Primary analysis used intention to treat (ITT). Mixed models and the log-rank test were used to assess the arm effect (PC vs. SC) on the course of abstinence and retention, respectively. In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively. This ITT analysis showed the non-inferiority of PC (21.5 [7.7; 35.3]). Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC. Retention in methadone and abstinence during follow-up were comparable in both arms (p = 0.47, p = 0.39, respectively). Under appropriate conditions, methadone induction in primary care is feasible and acceptable to both physicians and patients. It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence. Number Eudract 2008-001338-28; ClinicalTrials.gov: NCT00657397; International Standard Randomized Controlled Trial Number Register ISRCTN31125511
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DOI：
10.1111/j.1360-0443.2011.03700.x
发表时间：
2012-05
期刊：
Addiction (Abingdon, England)
影响因子：
--
作者：
Schwartz RP;Kelly SM;O'Grady KE;Gandhi D;Jaffe JH
通讯作者：
Jaffe JH
DOI：
10.1136/bmj.e5945
发表时间：
2012-10-03
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
MacArthur GJ;Minozzi S;Martin N;Vickerman P;Deren S;Bruneau J;Degenhardt L;Hickman M
通讯作者：
Hickman M
影响因子：
11.8
作者：
Carrieri, Maria Patrizia;Amass, Leslie;Woody, George E.
通讯作者：
Woody, George E.
影响因子：
2.3
作者：
Fareed, Ayman;Casarella, Jennifer;Drexler, Karen
通讯作者：
Drexler, Karen
影响因子：
6
作者：
Nosyk, Bohdan;Sun, Huiying;Anis, Aslam H.
通讯作者：
Anis, Aslam H.