Adjunctive Counseling During Brief and Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence A 2-Phase Randomized Controlled Trial
Adjunctive Counseling During Brief and Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence A 2-Phase Randomized Controlled Trial
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DOI：
10.1001/archgenpsychiatry.2011.121
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发表时间：
2011-12-01
影响因子：
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通讯作者：
Ling, Walter
中科院分区：
文献类型：
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作者：
Weiss, Roger D.;Potter, Jennifer Sharpe;Ling, Walter
内容：没有随机试验检查处方阿片类药物依赖的治疗，尽管其患病率不断上升。Objective：To evaluate efficacy of simple and extended buprenorphine hydrochloride-naloxone hydrochloride treatment，with different consultation intensities，for patients dependent on prescription opioids.Design：Multisite，randomized clinical trial using a 2-phase adaptive treatment research design.短期治疗（1期）包括2周丁丙诺啡-纳洛酮稳定、2周逐渐减量和8周给药后随访。成功使用阿片类药物的患者退出研究;不成功的患者进入第2阶段：延长（12周）丁丙诺啡-纳洛酮治疗，4周逐渐减量，8周用药后随访。设置：10个美国站点。患者：共653名依赖处方阿片类药物寻求治疗的门诊患者。干预措施：在这两个阶段中，患者被随机分配到标准医疗管理（SMM）或SMM加阿片类药物依赖咨询;所有患者均接受丁丙诺啡-纳洛酮治疗。根据尿液测试确认的自我报告，综合指标表明阿片类药物的使用量很少或没有使用。结果：在第一阶段，只有6.6%（653例中的43例）的患者取得了成功的结果，SMM和SMM加阿片类药物依赖咨询之间没有差异。相比之下，49.2%（360例中的177例）在延长丁丙诺啡-纳洛酮治疗（第12周）期间的第2阶段获得成功结局，咨询条件之间没有差异。完成丁丙诺啡-纳洛酮减量（第2阶段，第24周）后8周的成功率降至8.6%（31/360），再次没有咨询差异。在次要分析中，服用丁丙诺啡-纳洛酮的成功II期结局比减量后8周更常见（49.2% [360例中的177例] vs 8.6% [360例中的31例]，P
Context: No randomized trials have examined treatments for prescription opioid dependence, despite its increasing prevalence.Objective: To evaluate the efficacy of brief and extended buprenorphine hydrochloride-naloxone hydrochloride treatment, with different counseling intensities, for patients dependent on prescription opioids.Design: Multisite, randomized clinical trial using a 2-phase adaptive treatment research design. Brief treatment (phase 1) included 2-week buprenorphine-naloxone stabilization, 2-week taper, and 8-week postmedication follow-up. Patients with successful opioid use outcomes exited the study; unsuccessful patients entered phase 2: extended (12-week) buprenorphine-naloxone treatment, 4-week taper, and 8-week postmedication follow-up.Setting: Ten US sites.Patients: A total of 653 treatment-seeking outpatients dependent on prescription opioids.Interventions: In both phases, patients were randomized to standard medical management (SMM) or SMM plus opioid dependence counseling; all received buprenorphine-naloxone.Main Outcome Measures: Predefined "successful outcome" in each phase: composite measures indicating minimal or no opioid use based on urine test-confirmed self-reports.Results: During phase 1, only 6.6% (43 of 653) of patients had successful outcomes, with no difference between SMM and SMM plus opioid dependence counseling. In contrast, 49.2% (177 of 360) attained successful outcomes in phase 2 during extended buprenorphine-naloxone treatment (week 12), with no difference between counseling conditions. Success rates 8 weeks after completing the buprenorphine-naloxone taper (phase 2, week 24) dropped to 8.6% (31 of 360), again with no counseling difference. In secondary analyses, successful phase 2 outcomes were more common while taking buprenorphine-naloxone than 8 weeks after taper (49.2% [177 of 360] vs 8.6% [31 of 360], P