Varenicline and Motivational Advice for Smokers with SUD

描述(申请人提供)：物质使用障碍(SUD)患者吸烟率和吸烟率很高，但戒烟成功率很低，因此需要更强有力的方法来鼓励尝试戒烟。简明建议(BA)是一种旨在激励戒烟尝试的方法，对患有肥皂泡的吸烟者产生了一些好处，但戒烟率较低，同时增加了免费的经皮尼古丁替代疗法(NRT)，提高了短期戒烟率。Varenicline是A4？2烟碱型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对吸烟者产生更高的短期和长期戒断率。然而，尚未发表varenicline和NRT之间的疗效比较，也没有对患有肥胖症的人进行varenicline的研究。鉴于这些人群的标准吸烟治疗缺乏有效性，需要知道的是，当所有人都接受动机咨询时，varenicline是否会增加相对于NRT的戒烟率。这项研究的主要目的是通过两组随机安慰剂对照设计对274名接受SUD治疗的门诊患者12个月的戒烟率进行评估，并与NRT相比，评估12周的Varenicline的效果。咨询包括BA(通过直接解决药物滥用者表达的障碍和担忧，略微适应戒酒环境)、技能培训和药物管理。将在治疗开始后的3个月、6个月和12个月对确诊的时点流行率和持续戒断进行评估。二级目标将检查潜在的影响因素，包括治疗内的戒断、渴求和尼古丁戒断水平。潜在的意义是增加关于在药物滥用者中最有效地戒烟的知识，这一点很重要，因为目前还没有已知的方法来应对这些困难的人群。以前没有研究比较varenicline和NRT的疗效，也没有研究varenicline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.