INDIVIDUALIZING TREATMENT FOR ADDICTED SMOKERS

尼古丁替代仍然是迄今为止最有希望的烟草成瘾治疗方法。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。一个主要问题是如何防止戒烟尝试后再次吸烟。复发率高得令人失望(通常是75%-80%)，即使是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截然不同的研究。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性化治疗。我们的计划是测试一种程序的有效性，该程序通过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种治疗条件中的一种。300名受试者将接受个体化治疗，以取代戒烟前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衡量标准)。这一治疗程序的一个关键特点是密切监测停药后的可替宁水平，并在必要时随后调整剂量。另外300名吸烟者将获得固定标准或更高剂量的贴片，而不是量身定做的尼古丁替代品。这些吸烟者将提供剂量-反应控制条件，这将使我们能够将个性化治疗与只涉及标准剂量或更高剂量贴片的简单模型进行比较。最后一个由150名受试者组成的控制组将只给予安慰剂贴片，以允许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%替代尼古丁(即，将他们平时吸烟的尼古丁摄入量与尼古丁贴片相匹配)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尼古丁更替影响戒烟率的机制，研究尼古丁更替对重要吸烟者亚群(如女性、抑郁吸烟者、老年吸烟者)的影响，并调查除尼古丁更替程度外，可能与戒烟或复发有关的其他因素。结果将为尼古丁替代程度与通常尼古丁摄入量相匹配的假设提供一个明确、明确的测试，以提高戒烟率。如果这一假设得到支持，我们的发现将对烟瘾患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.