Cocaine vaccine for the treatment of cocaine dependence in methadone-maintained patients: a randomized, double-blind, placebo-controlled efficacy trial.
Cocaine vaccine for the treatment of cocaine dependence in methadone-maintained patients: a randomized, double-blind, placebo-controlled efficacy trial.
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DOI：
10.1001/archgenpsychiatry.2009.128
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发表时间：
2009-10
影响因子：
--
通讯作者：
Kosten, Thomas R.
中科院分区：
文献类型：
--
作者：
Martell, Bridget A.;Orson, Frank M.;Poling, James;Mitchell, Ellen;Rossen, Roger D.;Gardner, Tracie;Kosten, Thomas R.
每年影响250万美国人的可卡因依赖，没有FDA批准的药物疗法。评价治疗可卡因依赖的新型可卡因疫苗的免疫原性、安全性和有效性。24周IIb期随机双盲安慰剂对照试验，在8周至20周期间进行疗效评估，并随访至24周。2003-2005年从康涅狄格州大纽黑文招募的可卡因和阿片依赖者。115名美沙酮受试者(67%男性，87%高加索人，年龄18-46岁)随机接受疫苗或安慰剂治疗，82%完成了试验。大多数人吸食强效可卡因，同时使用大麻(18%)、酒精(10%)和非处方阿片类药物(44%)。在超过12周的时间里，109/115名受试者接受了5次与霍乱B蛋白有关的安慰剂或琥珀酸去可卡因疫苗接种。半定量尿液可卡因代谢物水平每周测量三次，阳性截止值为300 ng/ml。在接种疫苗的受试者中，在9至16周内，38%的接种者血清免疫球蛋白抗可卡因水平达到43微克/毫升(高免疫球蛋白)，其无可卡因尿量显著多于43微克/毫升(低免疫球蛋白)和安慰剂受试者(45%对35%)。高免疫球蛋白水平受试者可卡因使用量减少50%的比例显著高于低免疫球蛋白水平受试者(0.53比0.23)(P<；0.04)。最常见的副作用是注射部位硬化和压痛。没有与治疗相关的严重不良事件、停药或死亡。达到高水平(≥43微克/毫升)的可卡因抗体水平与可卡因使用显著减少有关，但只有38%的疫苗接种者达到这一水平，并且他们只有2个月的可卡因阻断时间。因此，我们需要改进的疫苗和增强剂。
Cocaine dependence, which affects 2.5 million Americans annually, has no FDA approved pharmacotherapy. To evaluate the immunogenicity, safety, and efficacy of a novel cocaine vaccine to treat cocaine dependence. 24 week Phase IIb randomized double-blind placebo-controlled trial with efficacy assessed during weeks 8 to 20 and follow-up to week 24. Cocaine and opioid dependent persons recruited from 2003–2005 from greater New Haven, CT. 115 methadone maintained subjects (67% male, 87% Caucasian, aged 18–46) were randomized to vaccine or placebo and 82% completed the trial. Most smoked crack cocaine along with using marijuana (18%), alcohol (10%), and non-prescription opioids (44%). Over 12 weeks 109/115 subjects received five vaccinations of placebo or succinylnorcocaine linked to cholera B protein. Semi-quantitative urinary cocaine metabolite levels measured thrice weekly with positive cutoff of 300 ng/ml. The 38% of vaccinated subjects who attained serum IgG anti-cocaine levels ≥ 43 µg/mL (high IgG) had significantly more cocaine-free urines than those with < 43 µg/mL (low IgG) and the placebo subjects during weeks 9 to 16 (45% vs 35%). The proportion of subjects having a 50% reduction in cocaine use was significantly greater in the high IgG than low IgG subjects (0.53 vs. 0.23) (P<0.04). The most common side effects were injection site induration and tenderness. There were no treatment related serious adverse events, withdrawals, or deaths. Attaining high (≥ 43 µg/mL) IgG anti-cocaine antibody levels was associated with significantly reduced cocaine use, but only 38% of the vaccinated attained these IgG levels and they had only 2 months of adequate cocaine blockade. Thus, we need improved vaccines and boosters.
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影响因子：
0.2
作者：
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通讯作者：
Boyd, B.
影响因子：
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