Martell Bridget A, Mitchell Ellen, Poling James, Gonsai Kishor, Kosten Thomas R
Section of General Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.
Biol Psychiatry. 2005 Jul 15;58(2):158-64. doi: 10.1016/j.biopsych.2005.04.032.
Cocaine abuse has no established pharmacotherapy, but active immunotherapy with a cocaine vaccine shows promise as a therapeutic intervention.
An open label, fourteen week, dose-escalation study evaluated the safety, immunogenicity, and clinical efficacy of a novel human cocaine vaccine (TA-CD) in eighteen cocaine dependent subjects. Ten subjects (400 microg total dose group) received four-100 microg injections over the course of eight weeks. Subsequently, eight subjects (2000 microg total dose group) received five-400 microg vaccinations over twelve weeks. Intent to treat analysis of thrice weekly urine toxicologies and cocaine antibody titers were compared.
Sixteen of 18 subjects completed the study. There were no serious adverse reactions and the vaccine was well tolerated. The 2000 microg total dose group had a significantly higher mean antibody titer response (2000 units) as compared to the 400 microg total dose group (1000 units) (p = .05). The 2000 microg group was more likely to maintain cocaine free urines than those in the 400 microg group (Z = -3.12, p = .002). Despite relapse in both groups, most reported an attenuation of cocaine's usual euphoric effects at the six month follow-up time points (63% in the 400 microg and 100% in the 2000 microg groups).
The conjugated cocaine vaccine was well tolerated and cocaine specific antibodies persisted at least six months. The likelihood of using cocaine decreased in subjects who received the more intense vaccination schedule.
可卡因滥用尚无既定的药物治疗方法，但使用可卡因疫苗进行主动免疫疗法显示出作为一种治疗干预手段的前景。
一项开放标签、为期十四周的剂量递增研究评估了一种新型人可卡因疫苗（TA-CD）在18名可卡因依赖受试者中的安全性、免疫原性和临床疗效。10名受试者（总剂量400微克组）在八周内接受了四次每次100微克的注射。随后，8名受试者（总剂量2000微克组）在十二周内接受了五次每次400微克的疫苗接种。对每周三次的尿液毒理学检查结果和可卡因抗体滴度进行意向性治疗分析并比较。
18名受试者中有16名完成了研究。未出现严重不良反应，疫苗耐受性良好。与400微克总剂量组（1000单位）相比，2000微克总剂量组的平均抗体滴度反应显著更高（2000单位）（p = 0.05）。2000微克组比400微克组更有可能保持尿液中无可卡因（Z = -3.12，p = 0.002）。尽管两组均有复发，但大多数受试者在六个月的随访时间点报告可卡因通常的欣快效应有所减弱（400微克组为63%，2000微克组为100%）。
结合型可卡因疫苗耐受性良好，可卡因特异性抗体至少持续六个月。接受更强免疫接种方案的受试者使用可卡因的可能性降低。
