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

项目摘要/摘要 该项目的长期目标是确定有心理健康问题的吸烟者可能对健康造成的影响 要求香烟中尼古丁含量极低的规则的条件(SMHC)，以及 含尼古丁电子烟(Ecigs)。这将在一项严格的随机对照试验中进行测试 设计。我们计划使用一套全面的经过验证的有效性和可重复性的衡量标准，包括 毒物暴露(尿NNAL，呼出的CO)，成瘾(FTND)和精神健康(Kessler K6)评估 这些影响。 这是一项前瞻性、平行组、随机、双盲、2x2对照试验，其中240 目前有心理健康问题的吸烟者将被随机分为4组：1)正常尼古丁 含量香烟(每支香烟11毫克尼古丁含量，NNC)和15毫克/毫升尼古丁；2)NNC和0 3)尼古丁含量极低的香烟(0.2 mg尼古丁/支，VLNC)和15 mg/mL 尼古丁提取物4)VLNCs和0 mg/mL尼古丁提取物。他们将对研究产品进行为期16周的跟踪调查 然后再过4周。参与者将首先完成初步的电话资格评估 还有一场面对面的放映。接下来，将安排一次面对面的评估访问，以完成通知 同意并确定资格。在吸食自己品牌的香烟一周后，参与者将 接受两周的NNC香烟，并被要求保留香烟日志。 合格的参与者将使用计算机算法随机分配到四组中的一组 由研究统计学家开发，由宾夕法尼亚州立大学调查药物药房监督。这个 药房还将准备盲烟和电子烟设备。所有研究产品将重新贴上标签，以确保 参与者和工作人员对尼古丁含量视而不见。在为期16周的随机阶段结束时， 参与者将来到他们的最后一次访问，获得戒烟的鼓励，并获得 社区资源，在那里他们可以接受戒烟咨询。参与者将被问及 提供有关他们持续使用烟草产品或戒烟的意图的信息，并将被遵守 4周后对这些结果进行评估。声称不再使用可燃烟草的人 将访问产品以验证呼出的CO的量度。

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.