Varenicline and Motivational Advice for Smokers with SUD

描述（由申请人提供）：物质使用障碍（SUD）人群吸烟患病率高，戒烟成功率低，因此需要更强有力的方法来鼓励戒烟尝试。简要建议（BA）是一种旨在激励戒烟尝试的方法，对患有sud的吸烟者产生了一些好处，但戒烟率较低，而添加免费透皮尼古丁替代疗法（NRT）可提高短期戒烟率。Varenicline是一种a4 - 2烟碱乙酰胆碱受体的部分激动剂，一般来说，它比安非他酮或安慰剂对吸烟者产生更高的短期和长期戒断率。然而，伐尼克兰和NRT疗效的比较尚未发表，也没有针对sud患者进行伐尼克兰的研究。考虑到对这一人群缺乏有效的标准吸烟治疗，需要知道的是，当所有人都接受动机性咨询时，相对于NRT，伐尼克兰是否会增加戒烟率。本研究的主要目的是评估12周varenicline与NRT的效果，采用两组随机安慰剂对照设计，对274例接受SUD治疗的门诊患者进行12个月的戒烟率。咨询包括BA（通过直接解决药物滥用者表达的障碍和担忧，略微适应清醒环境）、技能培训和药物管理。将在治疗开始后的3、6和12个月评估确定的点患病率和持续戒断。次要目的是研究潜在的影响因素，包括治疗期间的戒断、渴望和尼古丁戒断水平。这项研究的潜在意义在于增加了对药物滥用者中最大限度地戒烟的最有效方法的了解，鉴于目前还没有任何方法对这一困难人群有效，这一点很重要。此前没有研究将伐尼克兰与NRT的疗效进行比较，也没有研究伐尼克兰对SUD患者的疗效。

DESCRIPTION (provided by applicant): People with substance use disorders (SUD) have a high prevalence and rate of smoking with little success in quitting, so stronger approaches are needed to encourage attempts to quit smoking. Brief advice (BA), an approach designed to motivate cessation attempts, produced some benefit but low abstinence rates for smokers with SUDs while adding free transdermal nicotine replacement therapy (NRT) improved short-term rates. Varenicline, a partial agonist at a4¿2 nicotinic acetylcholine receptors, has been found to produce higher rates of short and long-term abstinence for smokers in general than bupropion or placebo. However, a comparison between the efficacy of varenicline and NRT has not yet been published and no studies of varenicline have been conducted with people with SUDs. Given the lack of effectiveness for standard smoking treatments for this population, what needs to be known is whether varenicline would increase the smoking abstinence rates relative to NRT when all receive motivational counseling. The primary aim of this study is to evaluate the effects of 12 weeks of varenicline as compared to NRT, using a two-group randomized placebo-controlled design on smoking cessation rates for 12 months among 274 outpatients in treatment for SUD. The counseling incorporates BA (adapted slightly for sobriety settings by directly addressing barriers and concerns expressed by substance abusers), skills training and medication management. Confirmed point-prevalence and sustained abstinence will be assessed at 3, 6 and 12 months after the start of treatment. Secondary aims will examine potential mediators of effect including within treatment abstinence, craving, and nicotine withdrawal levels. The potential significance is to add to knowledge about the most effective ways to maximize smoking cessation among substance abusers, important given that no methods are known to work with this difficult population. No previous study has compared varenicline to NRT for efficacy nor investigated varenicline with patients with SUD.