Varenicline and Motivational Advice for Smokers with SUD

描述（由申请人提供）：物质使用障碍（SUD）患者的吸烟率和患病率很高，戒烟成功率很低，因此需要更强有力的方法来鼓励尝试戒烟。简短建议（BA）是一种旨在激励戒烟尝试的方法，对SUD吸烟者产生了一些益处，但戒烟率较低，而添加免费经皮尼古丁替代疗法（NRT）可改善短期戒烟率。伐尼克兰，一种α 4 <$2烟碱乙酰胆碱受体的部分激动剂，已被发现比安非他酮或安慰剂一般能使吸烟者产生更高的短期和长期戒烟率。然而，伐尼克兰和NRT之间的疗效比较尚未发表，也没有对SUD患者进行伐尼克兰研究。鉴于标准吸烟治疗对这一人群缺乏有效性，需要知道的是，当所有人都接受动机咨询时，伐尼克兰是否会增加相对于NRT的戒烟率。本研究的主要目的是评价伐尼克兰12周与NRT相比对274例SUD门诊患者12个月戒烟率的影响，采用两组随机安慰剂对照设计。咨询包括BA（通过直接解决药物滥用者表达的障碍和担忧，稍微适应清醒环境），技能培训和药物管理。将在治疗开始后3、6和12个月评估确认的点患病率和持续戒断率。次要目的将检查潜在的效应介质，包括治疗戒断、渴望和尼古丁戒断水平。潜在的意义是增加关于最有效的方法的知识，以最大限度地减少药物滥用者的吸烟，重要的是，考虑到没有方法已知的工作与这个困难的人群。以前没有研究比较伐尼克兰与NRT的疗效，也没有研究伐尼克兰与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.