INDIVIDUALIZING TREATMENT FOR ADDICTED SMOKERS

尼古丁替代仍然是迄今为止治疗烟草成瘾最有希望的方法。然而，关于如何优化尼古丁替代疗法的有效性，仍然存在许多问题。一个主要的问题是如何防止在尝试戒烟后再次吸烟。复发率高得令人失望（通常为75% - 80%），即使对那些接受尼古丁替代治疗的人也是如此。我们计划进行一项与之前的尼古丁替代研究非常不同的研究。我们的研究将以任何疾病的医疗管理的基本概念为指导：根据每个人独特的生理特征进行个体化治疗。我们的计划是测试一个程序的有效性，该程序使用尼古丁贴片来调整尼古丁替代程度，以匹配吸烟者通常的尼古丁摄入量。我们将随机将750名吸烟者分配到5种治疗条件之一。300名受试者将接受个体化治疗，以替代戒烟前50%或100%的可替宁水平（可替宁是尼古丁的主要代谢物，提供尼古丁摄入量的稳定测量）。这种治疗程序的一个关键特点是在停药后密切监测可替宁水平，并在必要时调整剂量。另外300名吸烟者将获得固定标准或更高剂量的贴片，而不是定制尼古丁替代品。这些吸烟者将提供一个剂量-反应控制条件，这将使我们能够将个体化治疗与仅涉及标准或高剂量贴片的更简单模型进行比较。最后一个由150名受试者组成的对照组将只给予安慰剂贴片，以便与未接受治疗的情况进行比较。我们的中心假设是，那些接受量身定制的100%替代（即，用尼古丁贴片匹配他们通常吸烟的尼古丁摄入量）的人最有可能成功戒烟。我们还将测量相关的生物、行为和戒断变量。这些数据将使我们能够检查更多的尼古丁替代影响戒烟率的机制，研究更多的尼古丁替代对吸烟者重要亚群（例如，女性，抑郁吸烟者，老年吸烟者）的影响，并调查除了尼古丁替代程度之外，可能与戒烟或复发有关的其他因素。结果将提供一个清晰、明确的假设测试，即尼古丁替代的程度与通常的尼古丁摄入量相匹配可以提高戒烟率。如果这一假设得到支持，我们的发现将对吸烟成瘾者的治疗产生重大影响。

Nicotine replacement continues to be the most promising treatment to date for tobacco addiction. Many questions remain, however, concerning how to optimize the effectiveness of nicotine replacement therapies. A major issue is how to prevent relapse to smoking after a quit-smoking attempt. Relapse rates are disappointingly high (typically 75 percent-80 percent), even for those receiving nicotine replacement treatment. We have planned a study very different from previous studies of nicotine replacement. Our study will be guided by the basic concept that generally characterizes medical management of any disorder: individualization of treatment based upon physiological characteristics unique to each person. Our plan is to test the efficacy of a procedure for tailoring the degree of nicotine replacement to match the smoker's usual nicotine intake using nicotine patches. We will randomly assign 750 smokers to one of 5 treatment conditions. 300 subjects will be given individualized treatment to replace either 50 percent or 100 percent of their pre-quit cotinine levels (cotinine is a major metabolite of nicotine that provides a stable measure of nicotine intake). A key feature of this treatment procedure involves close monitoring of cotinine levels after cessation and subsequent adjustment of dose if necessary. An additional 300 smokers will be given fixed standard or higher-dose patches rather than tailored nicotine replacement. These smokers will provide a dose-response control condition, which will allow us to compare individualization of treatment with a simpler model involving just standard or higher-dose patches. A final control group of 150 subjects will be given only placebo patches, to allow comparisons with a no-treatment condition. Our central hypothesis is that those who receive tailored 100 percent replacement (i.e., matching their usual smoking nicotine intake with nicotine patches) will be the most likely to succeed in quitting. We will also measure relevant biological, behavioral, and withdrawal variables. These data will allow us to examine mechanisms by which greater nicotine replacement affects cessation rates, to study effects of greater nicotine replacement for important subgroups of smokers (e.g., women, depressed smokers, older smokers), and to investigate additional factors, besides degree of nicotine replacement, that may be related to abstinence or relapse. Results will provide a clear, definitive test of the hypothesis that matching the degree of nicotine replacement to usual nicotine intake improves cessation rates. If this hypothesis is supported, our findings will have major implications for the treatment of addicted smokers.