Randomized trial of long-acting sustained-release naltrexone implant vs oral naltrexone or placebo for preventing relapse to opioid dependence.
Randomized trial of long-acting sustained-release naltrexone implant vs oral naltrexone or placebo for preventing relapse to opioid dependence.
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DOI：
10.1001/archgenpsychiatry.2012.1a
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发表时间：
2012-09
影响因子：
--
通讯作者：
Woody, George E.
中科院分区：
文献类型：
--
作者：
Krupitsky, Evgeny;Zvartau, Edwin;Blokhina, Elena;Verbitskaya, Elena;Wahlgren, Valentina;Tsoy-Podosenin, Marina;Bushara, Natalia;Burakov, Andrey;Masalov, Dmitry;Romanova, Tatyana;Tyurina, Arina;Palatkin, Vladimir;Slavina, Tatyana;Pecoraro, Anna;Woody, George E.
缓释纳洛酮植入剂可改善阿片类药物成瘾非激动剂治疗的结局。比较纳洛酮植入剂、口服盐酸纳洛酮和非药物治疗的结局。为期6个月的双盲、双模拟、随机试验。俄罗斯圣彼得堡的戒毒项目。306名阿片类药物成瘾患者最近正在戒毒。每两周一次的咨询和以下3种治疗中的一种，持续24周：（1）1000 mg纳洛酮植入剂和口服安慰剂（NI+OP组; 102例患者）;（2）安慰剂植入剂和50 mg口服盐酸纳洛酮（PI+ON组; 102例患者）;或（3）安慰剂植入剂和口服安慰剂（PI+OP组; 102例患者）。继续接受治疗而未复发的患者百分比。到第6个月时，NI+OP组102例患者中有54例（52.9%）继续治疗而无复发，而PI+ON组102例患者中有16例（15.7%）（生存分析，对数秩检验，P<0.001），PI+OP组102例患者中有11例（10.8%）（P<0.001）。PI+ON与PI+OP的比较显示PI+ON组的优势不显著（P= 0.07）。将缺失的检测结果计为阳性，NI+OP组阿片类药物尿液筛查阴性结果的比例为63.6%（95% CI，60%-66%）; PI+ON组为42.7%（40%-45%）; PI+OP组为34.1%（32%-37%）（P<0.001，Fisher精确检验，与NI+OP组相比）。NI+OP组244例患者中发生12例伤口感染（4.9%），PI+ON组181例患者中发生2例伤口感染（1.1%），PI+OP组148例患者中发生1例伤口感染（0.7%）（P= 0.02）。所有事件均发生在植入后的前2周内，并通过抗生素治疗解决。NI+OP组在植入后第2个月发生了4例局部反应（发红和肿胀）（P= 0.12），所有反应均通过抗过敏药物治疗解决。NI+OP组886次访视中有8次（0.9%）、PI+ON组522次访视中有4次（0.8%）和PI + ON组394次访视中有3次（0.8%）报告了其他非局部部位不良反应;所有不良反应均已消退，无严重不良反应。没有证据表明纳洛酮治疗结束后过量死亡增加。植入比口服纳洛酮或安慰剂更有效。NI+OP组中发生伤口感染或局部刺激的患者多于其他组，但均不严重，且均在治疗后消退。
Sustained-release naltrexone implants may improve outcomes of nonagonist treatment of opioid addiction. To compare outcomes of naltrexone implants, oral naltrexone hydrochloride, and nonmedication treatment. Six-month double-blind, double-dummy, randomized trial. Addiction treatment programs in St Petersburg, Russia. Three hundred six opioid-addicted patients recently undergoing detoxification. Biweekly counseling and 1 of the following 3 treatments for 24 weeks: (1) 1000-mg naltrexone implant and oral placebo (NI+OP group; 102 patients); (2) placebo implant and 50-mg oral naltrexone hydrochloride (PI+ON group; 102 patients); or (3) placebo implant and oral placebo (PI+OP group; 102 patients). Percentage of patients retained in treatment without relapse. By month 6, 54 of 102 patients in the NI+OP group (52.9%) remained in treatment without relapse compared with 16 of 102 patients in the PI+ON group (15.7%) (survival analysis, log-rank test, P<.001) and 11 of 102 patients in the PI+OP group (10.8%) (P<.001). The PI+ON vs PI+OP comparison showed a nonsignificant trend favoring the PI+ON group (P=.07). Counting missing test results as positive, the proportion of urine screening tests yielding negative results for opiates was 63.6% (95% CI, 60%-66%) for the NI+OP group; 42.7% (40%-45%) for the PI+ON group; and 34.1% (32%-37%) for the PI+OP group (P<.001, Fisher exact test, compared with the NI+OP group). Twelve wound infections occurred among 244 implantations (4.9%) in the NI+OP group, 2 among 181 (1.1%) in the PI+ON group, and 1 among 148 (0.7%) in the PI+OP group (P=.02). All events were in the first 2 weeks after implantation and resolved with antibiotic therapy. Four local-site reactions (redness and swelling) occurred in the second month after implantation in the NI+OP group (P=.12), and all resolved with antiallergy medication treatment. Other nonlocal-site adverse effects were reported in 8 of 886 visits (0.9%) in the NI+OP group, 4 of 522 visits (0.8%) in the PI+ON group, and 3 of 394 visits (0.8%) in the PI+ON group; all resolved and none were serious. No evidence of increased deaths from overdose after naltrexone treatment ended was found. The implant is more effective than oral naltrexone or placebo. More patients in the NI+OP than in the other groups develop wound infections or local irritation, but none are serious and all resolve with treatment.
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影响因子：
6.7
作者：
Krupitsky, Evgeny;Zvartau, Edwin;Woody, George
通讯作者：
Woody, George
影响因子：
3.9
作者：
Krupitsky, EM;Zvartau, EE;Woody, GE
通讯作者：
Woody, GE
影响因子：
1.9
作者：
MCLELLAN, AT;LUBORSKY, L;OBRIEN, CP
通讯作者：
OBRIEN, CP
影响因子：
--
作者：
Hulse, Gary K.;Morris, Noella;Tait, Robert J.
通讯作者：
Tait, Robert J.
影响因子：
3.7
作者：
KAPLAN, EL;MEIER, P
通讯作者：
MEIER, P