Randomized trial of low nicotine cigarettes plus electronic cigarettes in smokers with a mental health condition

项目总结/摘要 该项目的长期目标是确定对心理健康的吸烟者可能产生的健康影响 要求香烟中尼古丁含量非常低的规则的条件（SMHC），以及 含尼古丁的电子香烟（EIGS）。这将在严格的随机对照试验中进行测试 设计我们计划使用一套经过验证的有效性和可重复性的综合措施，包括 毒物暴露（尿NNAL、呼出CO）、成瘾（FTND）和心理健康（Kessler K6），以评估 这些影响。 这是一项前瞻性平行组随机双盲、2 × 2对照试验，其中240例 将患有精神健康状况的当前吸烟者随机分为4组：1）正常尼古丁 尼古丁含量香烟（11 mg尼古丁含量/支，NNC）和15 mg/mL尼古丁香烟; 2）NNC和零 尼古丁含量极低的香烟（0.2mg尼古丁/支，VLNC）和15 mg/mL 4）VLNC和零mg/mL尼古丁烟。他们将接受为期16周的研究产品随访 然后再过四周参与者将首先完成初步的电话资格评估 和一次现场检查接下来，将安排一次亲自评估访问， 同意并确定资格。在吸自己品牌的香烟1周后，参与者将 接受2周的NNC香烟，并被要求保留香烟日志。 符合条件的参与者将被随机分配到四个组之一，使用计算机算法 由研究统计学家开发，并由宾夕法尼亚州立大学研究药物药房监督。的 药房还将准备盲烟和电子烟设备。所有研究产品将重新贴标，以确保 参与者和工作人员对尼古丁含量不知情。在16周随机化阶段结束时， 参加者将参加最后一次访问，鼓励他们戒烟，并获得 在社区的资源，他们可以接受戒烟咨询。参与者将被要求 提供关于他们正在使用或戒烟的意图的信息，并将遵循 4周后，我们将评估这些结果。声称不再使用可燃烟草的 将对产品进行访问，以通过测量呼出的CO进行验证。

Project Summary/Abstract The long term goal of this project is to determine the likely health effects in Smokers with Mental Health Conditions (SMHC) of a rule requiring very low nicotine content in cigarettes, in conjunction with availability of nicotine-containing electronic cigarettes (ecigs). This will be tested in a rigorous randomized controlled trial design. We plan to use a comprehensive set of measures of proven validity and reproducibility, including toxicant exposure (urinary NNAL, exhaled CO), addiction (FTND) and mental health (Kessler K6) to assess these effects. This is a prospective parallel-group randomized double-blind, 2-by-2 controlled trial in which 240 current smokers with mental health conditions will be randomized to one of 4 groups: 1) normal nicotine content cigarettes (11mg nicotine content per cigarette, NNCs) and 15mg/mL nicotine ecigs; 2) NNCs and zero mg/mL nicotine ecigs; 3) Very low nicotine content cigarettes (0.2mg nicotine/cigarette, VLNCs) and 15mg/mL nicotine ecigs 4) VLNCs and zero mg/mL nicotine ecigs. They will be followed for 16 weeks on study products and then another 4 weeks thereafter. Participants will first complete a preliminary phone eligibility assessment and an in-person screening. Next, an in person assessment visit will be scheduled to complete informed consent and determine eligibility. After 1 week of smoking their own brand of cigarettes, participants will receive 2 weeks of the NNC cigarettes and be asked to keep a cigarette log. Eligible participants will be randomly assigned to one of the four groups using a computer algorithm developed by study statisticians and overseen by the Penn State Investigational Drug Pharmacy. The Pharmacy will also prepare blinded cigarettes and e-cig devices. All study products will be relabeled to ensure participants and staff are blinded to the nicotine content. At the end of the 16-week randomization phase, participants will come to their last visit, receive encouragement to quit all tobacco products and be given resources in the community where they can receive smoking cessation counseling. Participants will be asked to provide information about their intentions for ongoing tobacco product use or cessation and will be followed up 4 weeks later to assess these outcomes. Those claiming to be no longer using combustible tobacco products will be visited to verify with a measure of exhaled CO.