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。 一个主要的问题是如何防止戒烟尝试后复吸。 复发率非常高（通常为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以往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。 我们的计划是测试使用尼古丁贴片定制尼古丁替代程度以匹配吸烟者通常尼古丁摄入量的程序的有效性。我们将750名吸烟者随机分配到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，可提供尼古丁摄入量的稳定指标）。 这种治疗程序的一个关键特征是在停药后密切监测可替宁水平，必要时随后调整剂量。 另外300名吸烟者将获得固定的标准或更高剂量的贴片，而不是定制的尼古丁替代品。 这些吸烟者将提供一个剂量反应控制条件，这将使我们能够比较个体化治疗与一个简单的模型，涉及只是标准或更高剂量的补丁。 最终对照组的150例受试者将仅给予安慰剂贴剂，以允许与未治疗条件进行比较。我们的中心假设是，那些接受定制的100%替代的人（即，用尼古丁贴片来匹配他们平时吸烟的尼古丁摄入量）将最有可能成功戒烟。 我们还将测量相关的生物学、行为学和戒断变量。 这些数据将使我们能够检查更多尼古丁替代影响戒烟率的机制，研究更多尼古丁替代对重要吸烟者亚组的影响（例如，女性、抑郁吸烟者、老年吸烟者），并调查除尼古丁替代程度外可能与戒烟或复吸有关的其他因素。结果将提供一个明确的，明确的假设测试，匹配尼古丁替代的程度，以平常的尼古丁摄入量提高戒烟率。 如果这一假设得到支持，我们的发现将对成瘾吸烟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.