Moderate- vs high-dose methadone in the treatment of opioid dependence - A randomized trial
Moderate- vs high-dose methadone in the treatment of opioid dependence - A randomized trial
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DOI：
10.1001/jama.281.11.1000
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发表时间：
1999-03-17
影响因子：
120.7
通讯作者：
Stitzer, ML
中科院分区：
文献类型：
--
作者：
Strain, EC;Bigelow, GE;Stitzer, ML
盐酸美沙酮治疗是阿片类药物依赖最常见的药物干预，最近的兴趣集中在扩大美沙酮治疗的可用性，超越传统的特许诊所。然而，尽管建议关于有效剂量的美沙酮，控制的临床试验，更高剂量的美沙酮还没有进行。目的比较相对临床疗效的中等剂量与高剂量美沙酮在治疗阿片类药物依赖。设计一个40周的随机，表示“双”之义1992年6月开始，1995年10月结束的一项盲法临床试验。背景：约翰霍普金斯大学药物滥用治疗研究门诊Bayview Campus，巴尔的摩，马里兰州。参与者192名合格的门诊患者。干预每日口服盐酸美沙酮，剂量范围为40至50 mg（n = 97）或80至100 mg（n = 95），同时进行药物滥用咨询。主要结果测量阿片类药物阳性尿分析结果和治疗保留率。结果通过意向治疗分析，第30周，高剂量组患者的阿片样物质阳性尿样率显著低于中等剂量组患者（53.0% [95%置信区间{CI}，46.9%-59.2%] vs 61.9% [95% CI，55.9%-68.0%]; P = 0.047）。这些差异在美沙酮戒断期间持续存在，直到第210天，剂量组之间在治疗保留方面没有显著差异（高剂量组平均滞留时间，159天;中剂量组平均保留时间，157天），高剂量组57例患者中有19例（33%）和中等剂量组54例患者中有11例（20%）完成了脱毒。高剂量美沙酮治疗导致美沙酮维持和脱毒期间非法阿片类药物使用减少，高剂量组非法阿片类药物使用减少显著。
Context Methadone hydrochloride treatment is the most common pharmacological intervention for opioid dependence, and recent interest has focused on expanding methadone treatment availability beyond traditional specially licensed clinics. However, despite recommendations regarding effective dosing of methadone, controlled clinical trials of higher-dose methadone have not been conducted.Objective To compare the relative clinical efficacy of moderate- vs high-dose methadone in the treatment of opioid dependence.Design A 40-week randomized, double-blind clinical trial starting in June 1992 and ending in October 1995.Setting Outpatient substance abuse treatment research clinic at the Johns Hopkins University Bayview Campus, Baltimore, Md.Participants One hundred ninety-two eligible clinic patients.Intervention Daily oral methadone hydrochloride in the dose range of 40 to 50 mg (n = 97) or 80 to 100 mg (n = 95), with concurrent substance abuse counseling.Main Outcome Measures Opioid-positive urinalysis results and retention in treatment.Results By intent-to-treat analysis, through week 30 patients in the high-dose group had significantly lower rates of opioid-positive urine samples compared with patients in the moderate-dose group (53.0% [95 % confidence interval {Cl}, 46.9% -59.2 %] vs 61.9% [95 % CI, 55.9 % -68.0 %]; P = .047). These differences persisted during withdrawal from methadone, Through day 210 no significant difference was evident between dose groups in treatment retention (high-dose group mean retention, 159 days; moderate-dose group mean retention, 157 days), Nineteen (33%) of 57 patients in the high-dose group and 11 (20%) of 54 patients in the moderate-dose group completed detoxification.Conclusions Both moderate- and high-dose methadone treatment resulted in decreased illicit opioid use during methadone maintenance and detoxification, The high-dose group had significantly greater decreases in illicit opiod use.