Very Low-Nicotine Cigarettes in Smokers with SUD: Smoking, Substance Use Effects

描述（由申请人提供）：2009年通过的《家庭吸烟预防和烟草控制法》（FSPTCA）授权食品和药物管理局（FDA）在适当的情况下降低香烟中的尼古丁水平，以保护公众健康。该项目涉及 这是NIH和FDA的研究目标，旨在评估毒性降低的产品对烟草使用行为的影响。在一些针对普通人群吸烟者的研究中，极低尼古丁含量香烟（VLNCC）相对于很少或没有补偿性吸烟的戒烟，可以减少对烟草的渴望和戒断，这表明强制降低香烟的尼古丁含量可以大幅降低吸烟率。这可能是一种特别有效的方法，可以减少烟草依赖率非常高的特殊人群（如物质使用障碍（SUD）患者）的吸烟和吸烟相关疾病。然而，这一政策对吸烟者SUD的后果尚未调查，并呼吁研究这些产品对这些脆弱人群的安全性。本研究的目的是确定VLNCC在SUD吸烟者（当前或过去一年）中的疗效、可接受性和非预期后果。主要目的是确定VLNCC是否会增加SUD吸烟者相对于基线和随机接受正常尼古丁含量香烟（NNCC）的吸烟者的戒烟率并减少吸烟、可替宁和毒性生物标志物，并确定VLNCC对物质使用和使用物质渴望的任何非预期影响，以研究安全性。次要目的是研究对吸烟渴望和尼古丁戒断和依赖（机制）以及状态抑郁（安全性）的影响。通过前后设计的2组组间将比较6周VLNCC与NNCC;还将为所有吸烟者提供吸烟咨询。6个月以上的随访将评估恢复正常吸烟后的效果。重要的是在确定这一健康战略的可行性和安全性方面的影响吸烟和其他物质的使用在一个高度上瘾的人口，这是必不可少的，以确定之前，FDA实施这一政策。

DESCRIPTION (provided by applicant): The 2009 passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) gave the Food and Drug Administration (FDA) the authority to reduce levels of nicotine in cigarettes if appropriate for public health. This project addresses an area targeted for study by NIH and the FDA to assess the impact of products with reduced toxicity on tobacco use behaviors. Very-low nicotine content cigarettes (VLNCC) have been shown in some studies with smokers from the general population to reduce craving and withdrawal for tobacco relative to abstinence with little or no compensatory smoking, suggesting that a mandated reduction in the nicotine yield of cigarettes could substantially reduce smoking rates. This may be a particularly effective method of reducing smoking and smoking-related disease in special populations that have very high rates of tobacco dependence, such as people with substance use disorders (SUD). However, the consequences of this policy for smokers with SUD have not been investigated, and a call has gone out for studies of the safety of these products with vulnerable populations such as these. The purpose of this study is to determine the efficacy, acceptability and unintended consequences of VLNCC in smokers with SUD (current or past year). The primary aims are to determine whether VLNCC will increase smoking cessation and reduce cigarette use, cotinine, and biomarkers of toxicity in smokers with SUD relative to baseline and to those randomized to a normal nicotine content cigarette (NNCC), and to determine any unintended effects of VLNCC on substance use and cravings to use substances so as to investigate safety. Secondary aims are to study effects on cigarette craving and nicotine withdrawal and dependence (mechanisms), and state depression (safety). A 2-group between-group by pre-post design will compare 6 weeks of VLNCC to NNCC; all smokers will also be provided with smoking counseling. Follow-up over 6 months will assess effects after return to usual cigarettes. The importance is in determining the viability and safety of this publi health strategy in terms of effects on both smoking and other substance use in a highly addicted population, which is essential to determine before the FDA implements this policy.