Department of Psychiatry, St. Luke's-Roosevelt Hospital Center, Columbia University College of Physicians and Surgeons, New York, NY, USA.
Addiction. 2013 Dec;108(12):2141-9. doi: 10.1111/add.12315. Epub 2013 Sep 18.
To evaluate the safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open-label sublingual buprenorphine/naloxone tablets (BNX).
Randomized, double-blind, placebo-controlled trial. Subjects received either four buprenorphine implants (80 mg/implant) (n = 114), four placebo implants (n = 54) or open-label BNX (12-16 mg/day) (n = 119).
Twenty addiction treatment centers.
Adult out-patients (ages 18-65) with DSM-IV-TR opioid dependence.
The primary efficacy end-point was the percentage of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF).
The BI CDF was significantly different from placebo (P < 0.0001). Mean [95% confidence interval (CI)] proportions of urines negative for opioids were: BI = 31.2% (25.3, 37.1) and PI = 13.4% (8.3, 18.6). BI subjects had a higher study completion rate relative to placebo (64 versus 26%, P < 0.0001), lower clinician-rated (P < 0.0001) and patient-rated (P < 0.0001) withdrawal, lower patient-ratings of craving (P < 0.0001) and better subjects' (P = 0.031) and clinicians' (P = 0.022) global ratings of improvement. BI also resulted in significantly lower cocaine use (P = 0.0016). Minor implant-site reactions were comparable in the buprenorphine [27.2% (31 of 114)] and placebo groups [25.9% (14 of 54)]. BI were non-inferior to BNX on percentage of urines negative for opioids [mean (95% CI) = 33.5 (27.3, 39.6); 95% CI for the difference of proportions = (-10.7, 6.2)].
Compared with placebo, buprenorphine implants result in significantly less frequent opioid use and are non-inferior to sublingual buprenorphine/naloxone tablets.
评估丁丙诺啡植入物（BI）与安慰剂植入物（PI）治疗阿片类药物依赖的安全性和疗效。次要目的是将 BI 与开放标签丁丙诺啡/纳洛酮舌下片（BNX）进行比较。
随机、双盲、安慰剂对照试验。受试者接受丁丙诺啡植入物（80mg/植入物）（n=114）、安慰剂植入物（n=54）或开放标签 BNX（12-16mg/天）（n=119）各 4 次。
二十个戒毒治疗中心。
成年门诊患者（年龄 18-65 岁），符合 DSM-IV-TR 阿片类药物依赖标准。
主要疗效终点是从第 1 周到第 24 周收集的尿液样本中阿片类药物阴性的百分比，作为累积分布函数（CDF）进行检测。
BI 的 CDF 与安慰剂有显著差异（P<0.0001）。尿液中阿片类药物阴性的平均[95%置信区间（CI）]比例分别为：BI=31.2%（25.3，37.1）和 PI=13.4%（8.3，18.6）。BI 组的研究完成率相对安慰剂组更高（64%比 26%，P<0.0001），医生评定（P<0.0001）和患者评定（P<0.0001）的戒断症状较轻，患者自评的渴求感（P<0.0001）较低，以及受试者（P=0.031）和医生（P=0.022）的总体改善评分更高。BI 还显著降低了可卡因的使用（P=0.0016）。丁丙诺啡[27.2%（31/114）]和安慰剂组[25.9%（14/54）]的植入部位反应发生率相当。BI 在尿液中阿片类药物阴性的比例上不劣于 BNX[平均（95%CI）=33.5%（27.3，39.6）；95%CI 比值的差异=-10.7，6.2]。
与安慰剂相比，丁丙诺啡植入物可显著减少阿片类药物的使用，且不劣于丁丙诺啡/纳洛酮舌下片。
