Buprenorphine Implants for Treatment of Opioid Dependence A Randomized Controlled Trial
Buprenorphine Implants for Treatment of Opioid Dependence A Randomized Controlled Trial
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DOI：
10.1001/jama.2010.1427
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发表时间：
2010-10-13
影响因子：
120.7
通讯作者：
Beebe, Katherine L.
中科院分区：
文献类型：
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作者：
Ling, Walter;Casadonte, Paul;Beebe, Katherine L.
现有药物治疗阿片类药物依赖的局限性包括低依从性、药物转移和戒断症状的出现。目的探讨丁丙诺啡植入物治疗阿片类药物依赖的效果，该植入物可在6个月内提供稳定的低剂量丁丙诺啡。2007年4月至2008年6月在美国18个地点进行的一项随机、安慰剂对照、为期6个月的试验。163名18至65岁的成年人被诊断为阿片类药物依赖。108人随机接受丁丙诺啡植入，55人接受安慰剂植入。在舌下丁丙诺啡-纳洛酮片诱导后，患者接受4次丁丙诺啡植入物（每次植入物80 mg）或4次安慰剂植入物。如果超过舌下丁丙诺啡-纳洛酮治疗的抢救阈值，则可以进行第五次植入。为所有患者提供标准化的个体化药物咨询。1 - 16周和17 - 24周非法阿片类药物尿样呈阴性的百分比。结果丁丙诺啡植入组第1 ~ 16周违禁阿片类药物阴性尿样明显多于丁丙诺啡植入组（P= 0.04）。植入丁丙诺啡的患者在第1周至第16周的尿液样本中非法阿片类药物检测呈阴性的平均百分比为40.4%(95%置信区间[CI]， 34.2%-46.7%)，中位数为40.7%；而安慰剂组的平均值为28.3% (95% CI, 20.3%-36.3%)，中位数为20.8%。108例接受丁丙诺啡植入的患者中有71例（65.7%）完成了研究，而55例接受安慰剂植入的患者中有17例（30.9%）完成了研究
Context Limitations of existing pharmacological treatments for opioid dependence include low adherence, medication diversion, and emergence of withdrawal symptoms.Objective To determine the efficacy of buprenorphine implants that provide a low, steady level of buprenorphine over 6 months for the treatment of opioid dependence.Design, Setting, and Participants A randomized, placebo-controlled, 6-month trial conducted at 18 sites in the United States between April 2007 and June 2008. One hundred sixty-three adults, aged 18 to 65 years, diagnosed with opioid dependence. One hundred eight were randomized to receive buprenorphine implants and 55 to receive placebo implants.Intervention After induction with sublingual buprenorphine-naloxone tablets, patients received either 4 buprenorphine implants (80 mg per implant) or 4 placebo implants. A fifth implant was available if a threshold for rescue use of sublingual buprenorphine-naloxone treatment was exceeded. Standardized individual drug counseling was provided to all patients.Main Outcome Measure The percentage of urine samples negative for illicit opioids for weeks 1 through 16 and for weeks 17 through 24.Results The buprenorphine implant group had significantly more urine samples negative for illicit opioids during weeks 1 through 16 (P=.04). Patients with buprenorphine implants had a mean percentage of urine samples that tested negative for illicit opioids across weeks 1 through 16 of 40.4% (95% confidence interval [CI], 34.2%-46.7%) and a median of 40.7%; whereas those in the placebo group had a mean of 28.3% (95% CI, 20.3%-36.3%) and a median of 20.8%. A total of 71 of 108 patients (65.7%) who received buprenorphine implants completed the study vs 17 of 55 (30.9%) who received placebo implants (P