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

对有心理健康状况的吸烟者进行低尼古丁香烟加电子烟的随机试验

• 批准号: 10229461
• 负责人: JONATHAN FOULDS
• 金额: $ 44.85万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10229461
• 关键词: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol; Address; Biochemical; Biological Markers; Blinded; Cigarette; Communities; Computational algorithm; Consumption; Counseling; Databases; Dependence; Devices; Diagnosis; Distress; Double-Blind Method; Electronic cigarette; Eligibility Determination; Ensure; Exhalation; Family Smoking Prevention and Tobacco Control Act; Goals; Health; Informed Consent; Infrastructure; International; Interview; Investigational Drugs; Measures; Mental Health; Nicotine; Nicotine Dependence; Outcome; Participant; Persons; Pharmacy facility; Phase; Placebos; Policies; Psyche structure; Randomized; Randomized Controlled Trials; Regulation; Reproducibility; Research; Resources; Risk; Sampling; Schedule; Smoke; Smoker; Smoking; Source; Standardization; Telephone; Testing; Tobacco use; Toxicant exposure; Urine; Visit; Work; addiction; behavioral health; cigarette addiction; cigarette smoking; cohort; combustible cigarette; combustible tobacco; design; electronic cigarette use; eligible participant; follow-up; improved; innovation; low nicotine content cigarette; neuropsychiatry; nicotine use; non-compliance; prospective; randomized trial; recruit; screening; smoking cessation; tobacco products; toxicant; trial design; urinary; volunteer

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.

项目摘要/摘要 该项目的长期目标是确定心理健康吸烟者的健康影响 一项规则的条件（SMHC），卷烟中需要非常低的尼古丁含量以及可用性 含尼古丁的电子烟（ECIGS）。这将在严格的随机对照试验中进行测试 设计。我们计划使用一套全面的有效性和可重复性的度量，包括 毒物暴露（尿液，呼气CO），成瘾（FTND）和心理健康（Kessler K6）评估 这些影响。 这是一项前瞻性平行组随机双盲，2 by-2对照试验，其中240 当前患有精神健康状况的吸烟者将被随机分为4组之一：1）正常尼古丁 含量香烟（每烟11mg尼古丁含量，NNCS）和15mg/ml尼古丁Ecigs； 2）NNC和零 mg/ml尼古丁ecigs； 3）非常低的尼古丁含量香烟（0.2mg尼古丁/香烟，VLNC）和15mg/ml 尼古丁ECIGS 4）VLNC和零mg/ml尼古丁ECIGS。他们将在研究产品上遵循16周 然后再进行4周。参与者将首先完成初步电话资格评估 和面对面的筛查。接下来，将安排亲自评估访问来完成知情 同意并确定资格。在抽烟1周后，参与者将 接受2周的NNC香烟，并要求保留香烟。 合格的参与者将使用计算机算法随机分配给四组之一 由研究统计学家开发，并由宾夕法尼亚州立调查药物药房监督。这 药房还将准备盲烟和电子烟设备。所有研究产品都将被重新标记以确保 参与者和工作人员对尼古丁含量视而不见。在16周的随机阶段结束时， 参与者将上次访问，受到鼓励退出所有烟草产品并获得 社区中他们可以接受戒烟咨询的资源。会问参与者 提供有关其持续烟草产品使用或停止意图的信息，并将遵循 4周后增加来评估这些结果。那些声称不再使用可燃烟草的人 将访问产品以使用呼出的CO进行验证。