A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers

描述(由申请人提供)：增加戒烟不仅可以通过增加给定戒烟尝试的成功率，还可以通过增加戒烟尝试的概率来实现。尽管政策干预增加了戒烟尝试，但临床医生激励个人吸烟者进行戒烟尝试的为数不多的治疗方法效果要么很小，要么不一致。考虑到过去十年吸烟者戒烟尝试的发生率并没有增加，这一点尤其成问题。一种广泛使用的促使严肃戒烟尝试的方法是鼓励实践戒烟尝试，就像美国大戒烟(GAS)和世界无烟日(WNSD)所做的那样。我们假设，在戒烟尝试中提供尼古丁替代疗法(NRT)将使戒烟尝试更加成功，减少不适感，从而增加后来有目的地尝试永久戒烟的可能性。我们之前的一项研究和其他研究表明，在没有戒烟动机的吸烟者中，提供NRT来减少每天吸烟会增加他们未来的戒烟尝试，但没有人测试过使用NRT来帮助实践戒烟是否也能做到这一点。我们相信，提供NRT将减少戒酒期间的痛苦，产生对使用NRT的更积极的态度，并提高戒烟的自我效能。有趣的是，其他人的假设正好相反；也就是说，为终身禁欲以外的目标提供的NRT将减少而不是增加未来的戒烟尝试。我们建议进行一项随机临床试验，包括a)简短建议进行a=24小时的戒烟尝试或b)简短建议加免费的NRT。试验方法将与我们之前的研究非常相似。以人群为基础的744名无动机吸烟者的样本将通过随机数字拨号和行为测试招募，只包括那些目前没有戒烟计划的人。所有治疗和评估将通过电话和邮寄方式提供。虽然我们的研究将评估一些戒烟尝试的定义，但我们的主要结果是在六个月的研究期间发生了严重的永久戒烟尝试。我们还将评估普遍存在的节欲作为次要结果，并将测试我们假设的任何NRT影响的中介因素。如果成功，这项研究将1)为临床医生提供一种新的治疗选择，以激励吸烟者尝试戒烟，2)测试使用非戒烟结果的NRT破坏戒烟的假设是否正确，3)建议重新标记非处方药NRT的测试，包括用于非戒烟目的的测试，如实践戒烟尝试和向个人提供NRT样本的测试。

DESCRIPTION (provided by applicant): Increasing smoking cessation can be accomplished not only by increasing the success of a given quit attempt but also by increasing the probability of making a quit attempt. Although policy interventions increase quit attempts, the few treatments for clinicians to motivate individual smokers to make a quit attempt have either small or inconsistent effects. This is especially problematic given the incidence of quit attempts among smokers over the past decade is not increasing. One widely used method to prompt serious quit attempts is to encourage practice-quit attempts as is done by the Great American Smoke out (GAS) and World No Smoking Day (WNSD). We hypothesize providing nicotine replacement therapy (NRT) to use in a practice-quit attempt will make the attempt more successful and less uncomfortable and thus increase the probability of later purposeful attempts to quit smoking permanently. A prior study of ours and other studies have shown that providing NRT to reduce cigarettes per day in smokers not motivated to quit increases their future quit attempts, but no one has tested whether using NRT to aid practice quit attempts also does so. We believe providing NRT will reduce distress during abstinence, produce more favorable attitudes to using NRT and increase self-efficacy for quitting. Interestingly, others have hypothesized the opposite; i.e. that the provision of NRT for goals other than life-long abstinence will decrease rather than increase future quit attempts. We propose a randomized clinical trial of a) brief advice to undertake a = 24 hr practice quit attempt or b) brief advice plus free NRT. Trial methods will be very similar to our prior study. A population-based sample of 744 unmotivated smokers will be recruited via random-digit dialing and a behavioral test to include only those with no current plans to quit. All treatments and assessments will be delivered via telephone and mailings. Though our study will assess a number of quit attempt definitions, our primary outcome is the incidence of a serious attempt to permanently stop smoking made over a six-month study period. We will also assess point prevalent abstinence as a secondary outcome and will test our hypothesized mediators of any NRT effects. If successful, this study will 1) offer a new treatment option for clinicians to motivate smokers to try to quit, 2) test whether the hypothesis that using NRT for non-abstinence outcomes undermines abstinence is correct, and 3) suggest tests of relabeling over-the-counter NRT to include use for non-cessation purposes such as practice quit attempts and tests of providing NRT samples to individuals.