Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone
Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone
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DOI：
10.1056/nejmoa022164
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发表时间：
2003-09-04
影响因子：
158.5
通讯作者：
Tusel, D
中科院分区：
文献类型：
--
作者：
Fudala, PJ;Bridge, TP;Tusel, D
背景：已经提出在办公室用丁丙诺啡和纳洛酮舌下片剂配方治疗阿片类药物成瘾，但其功效和安全性尚未得到充分研究。方法：我们进行了一项多中心、随机、安慰剂对照试验，涉及 326 名阿片类药物成瘾者，他们被分配到办公室接受由丁丙诺啡（16 毫克）联合纳洛酮（4 毫克）组成的舌下片剂治疗，单独使用丁丙诺啡（16 毫克），或每天服用安慰剂，持续四个星期。主要结果指标是尿液样本中阿片类药物呈阴性的百分比以及受试者自我报告的对阿片类药物的渴望。安全性数据来自参与一项丁丙诺啡和纳洛酮（每日剂量分别高达 24 毫克和 6 毫克）开放标签研究的 461 名阿片类成瘾者以及仅在试验期间接受该组合治疗的另外 11 名受试者。 结果：双盲试验提前终止，因为发现丁丙诺啡和纳洛酮组合以及单独使用丁丙诺啡比安慰剂具有更好的疗效。联合治疗组和丁丙诺啡组中阿片类药物呈阴性的尿液样本比例（分别为 17.8% 和 20.7%）高于安慰剂组（5.8%，P
Background: Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone has been proposed, but its efficacy and safety have not been well studied.Methods: We conducted a multicenter, randomized, placebo-controlled trial involving 326 opiate-addicted persons who were assigned to office-based treatment with sublingual tablets consisting of buprenorphine (16 mg) in combination with naloxone (4 mg), buprenorphine alone (16 mg), or placebo given daily for four weeks. The primary outcome measures were the percentage of urine samples negative for opiates and the subjects' self-reported craving for opiates. Safety data were obtained on 461 opiate-addicted persons who participated in an open-label study of buprenorphine and naloxone (at daily doses of up to 24 mg and 6 mg, respectively) and another 11 persons who received this combination only during the trial.Results: The double-blind trial was terminated early because buprenorphine and naloxone in combination and buprenorphine alone were found to have greater efficacy than placebo. The proportion of urine samples that were negative for opiates was greater in the combined-treatment and buprenorphine groups (17.8 percent and 20.7 percent, respectively) than in the placebo group (5.8 percent, P