A PLACEBO-CONTROLLED CLINICAL-TRIAL OF BUPRENORPHINE AS A TREATMENT FOR OPIOID DEPENDENCE
A PLACEBO-CONTROLLED CLINICAL-TRIAL OF BUPRENORPHINE AS A TREATMENT FOR OPIOID DEPENDENCE
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DOI：
10.1016/0376-8716(95)01186-2
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发表时间：
1995-11-01
影响因子：
4.2
通讯作者：
BIGELOW, GE
中科院分区：
文献类型：
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作者：
JOHNSON, RE;EISSENBERG, T;BIGELOW, GE
评估药物治疗药物依赖疗效的大规模安慰剂对照临床试验一般仅限于酒精、可卡因和尼古丁依赖人群。本研究的目的是评估丁丙诺啡与安慰剂在阿片类药物依赖人群中的早期（1-2周）临床有效性。该研究使用了一种具有行为选择成分的平行组设计，以比较丁丙诺啡（一种μ阿片类部分激动剂）与安慰剂治疗阿片类药物依赖。阿片类药物依赖志愿者患者参加了一项为期14天的研究，以评估这种新药物治疗阿片类药物依赖的有效性和患者接受度。患者被随机分配到安慰剂组（n = 60）或2 mg（n = 60）或8 mg（n = 30）每日舌下丁丙诺啡组。所有剂量均以双盲方式给药。在第6-13天，所有患者都可以要求改变剂量，知道他们的新剂量将从剩余的2种替代方案中随机选择。与安慰剂相比，给予丁丙诺啡（与剂量无关）的患者显示初始剂量的时间更长，要求的剂量变化更少，使用的非法阿片类药物更少（通过尿液分析评估），并且评定的剂量充足性更高。这些结果表明，具有行为选择成分的安慰剂对照研究是评估阿片类药物依赖新药物治疗的潜在疗效和可接受性的有效方法。
Large-scale placebo controlled clinical trials assessing the efficacy of medications for the treatment of drug dependence have generally been limited to alcohol, cocaine and nicotine dependent populations. The purpose of the present study was to assess the early (1-2 week) clinical effectiveness of buprenorphine versus placebo in an opioid dependent population. The study used a parallel-group design with a behavioral choice component to compare buprenorphine (a mu-opioid partial agonist) to placebo for the treatment of opioid dependence. Opioid dependent volunteer patients participated in a 14-day study to assess the effectiveness and patient acceptance of this new pharmacotherapy for the treatment of opioid dependence. Patients were randomly assigned to placebo (n = 60) or 2 mg (n = 60) or 8 mg (n = 30) daily sublingual buprenorphine. All doses were administered double-blind. On days 6-13 all patients could request a dose change, knowing that their new dose would be randomly chosen from the remaining 2 alternatives. Compared to placebo, patients given buprenorphine (independent of dose) showed greater time on initial dose, requested fewer dose changes, used less illicit opioids (assessed by urinalysis), and rated dose adequacy higher. These results demonstrate that a placebo controlled study with a behavioral choice component is an effective means of assessing the potential efficacy and acceptability of new pharmacotherapies for opioid dependence.