Primary care-based buprenorphine taper vs maintenance therapy for prescription opioid dependence: a randomized clinical trial.
Primary care-based buprenorphine taper vs maintenance therapy for prescription opioid dependence: a randomized clinical trial.
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DOI：
10.1001/jamainternmed.2014.5302
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发表时间：
2014-12
影响因子：
39
通讯作者：
O'Connor PG
中科院分区：
文献类型：
--
作者：
Fiellin DA;Schottenfeld RS;Cutter CJ;Moore BA;Barry DT;O'Connor PG
处方类阿片依赖呈上升趋势，并造成了重大的公共卫生负担，但初级保健医生缺乏循证指南来决定是逐渐减少盐酸丁丙诺啡和盐酸纳洛酮治疗（以下简称丁丙诺啡治疗）的剂量然后停药，还是进行持续的维持治疗。
为确定在初级保健中针对处方类阿片依赖的治疗里，丁丙诺啡逐渐减量与持续维持治疗的疗效。
我们从2009年2月17日至2013年2月1日在一个初级保健站点进行了一项为期14周的随机临床试验，招募了113名处方类阿片依赖患者。
患者被随机分配到丁丙诺啡逐渐减量组（减量条件）或持续丁丙诺啡维持治疗组（维持条件）。丁丙诺啡减量在稳定治疗6周后开始，持续3周，并包括用于阿片戒断的药物，之后为患者提供纳曲酮治疗。维持组接受持续的丁丙诺啡治疗。所有患者都得到了医生和护士的支持以及药物咨询。
通过尿液分析结果和患者报告的非法阿片使用情况、治疗保留情况以及丁丙诺啡治疗的重新开始情况（仅减量组）。
在试验期间，减量组患者尿液样本中阿片类物质呈阴性的平均百分比（35.2%[95%置信区间，26.2% - 44.2%]）低于维持组患者（53.2%[95%置信区间，44.3% - 62.0%]）。一旦不再接受丁丙诺啡治疗，减量组患者每周报告的非法阿片使用天数比维持组患者多（平均使用天数，1.27[95%置信区间，0.60 - 1.94]天对比0.47[95%置信区间，0.19 - 0.74]天）。与维持组患者相比，减量组患者连续戒断阿片的最长周数更少（平均戒断周数，2.70[95%置信区间，1.72 - 3.75]周对比5.20[95%置信区间，4.16 - 6.20]周）。减量组患者完成试验的可能性更小（57人中有6人[11%]对比56人中有37人[66%]；P <.001）。减量组中有16名患者由于复发在减量后重新开始丁丙诺啡治疗。
在初级保健中接受丁丙诺啡治疗的处方类阿片依赖患者中，逐渐减量不如持续维持治疗有效。
clinicaltrials.gov标识符：NCT00555425
Prescription opioid dependence is increasing and creates a significant public health burden, but primary care physicians lack evidence-based guidelines to decide between tapering doses followed by discontinuation of buprenorphine hydrochloride and naloxone hydrochloride therapy (hereinafter referred to as buprenorphine therapy) or ongoing maintenance therapy. To determine the efficacy of buprenorphine taper vs ongoing maintenance therapy in primary care–based treatment for prescription opioid dependence. We conducted a 14-week randomized clinical trial that enrolled 113 patients with prescription opioid dependence from February 17, 2009, through February 1, 2013, in a single primary care site. Patients were randomized to buprenorphine taper (taper condition) or ongoing buprenorphine maintenance therapy (maintenance condition). The buprenorphine taper was initiated after 6 weeks of stabilization, lasted for 3 weeks, and included medications for opioid withdrawal, after which patients were offered naltrexone treatment. The maintenance group received ongoing buprenorphine therapy. All patients received physician and nurse support and drug counseling. Illicit opioid use via results of urinanalysis and patient report, treatment retention, and reinitiation of buprenorphine therapy (taper group only). During the trial, the mean percentage of urine samples negative for opioids was lower for patients in the taper group (35.2% [95% CI, 26.2%−44.2%]) compared with those in the maintenance group (53.2% [95% CI, 44.3%−62.0%]). Patients in the taper group reported more days per week of illicit opioid use than those in the maintenance group once they were no longer receiving buprenorphine (mean use, 1.27 [95% CI, 0.60–1.94] vs 0.47 [95% CI,0.19–0.74] days). Patients in the taper group had fewer maximum consecutive weeks of opioid abstinence compared with those in the maintenance group (mean abstinence, 2.70 [95% CI, 1.72–3.75] vs 5.20 [95% CI, 4.16–6.20] weeks). Patients in the taper group were less likely to complete the trial (6 of 57 [11%] vs 37 of 56 [66%]; P < .001). Sixteen patients in the taper group reinitiated buprenorphine treatment after the taper owing to relapse. Tapering is less efficacious than ongoing maintenance treatment in patients with prescription opioid dependence who receive buprenorphine therapy in primary care. clinicaltrials.gov Identifier: NCT00555425
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