Wall Catherine S, Bono Rose S, Lester Rebecca C, Hoetger Cosima, Lipato Thokozeni, Guy Mignonne C, Eissenberg Thomas E, Bickel Warren K, Barnes Andrew J, Cobb Caroline O
Department of Health Behavior and Policy, Virginia Commonwealth University, Richmond, Virginia, USA.
Department of Psychology, Virginia Commonwealth University, Richmond, Virginia, USA.
BMJ Open. 2018 Oct 10;8(10):e023850. doi: 10.1136/bmjopen-2018-023850.
In the USA, Food and Drug Administration regulations prohibit the sale of flavoured cigarettes, with menthol being the exception. However, the manufacture, advertisement and sale of flavoured cigar products are permitted. Such flavourings influence positive perceptions of tobacco products and are linked to increased use. Flavourings may mask the taste of tobacco and enhance smoke inhalation, influencing toxicant exposure and abuse liability among novice tobacco users. Using clinical laboratory methods, this study investigates how flavour availability affects measures of abuse liability in young adult cigarette smokers. The specific aims are to evaluate the effect of cigar flavours on nicotine exposure, and behavioural and subjective measures of abuse liability.
Participants (projected n=25) are healthy smokers of five or more cigarettes per day over the past 3 months, 18-25 years old, naive to cigar use (lifetime use of 50 or fewer cigar products and no more than 10 cigars smoked in the past 30 days) and without a desire to quit cigarette smoking in the next 30 days. Participants complete five laboratory sessions in a Latin square design with either their own brand cigarette or a session-specific Black & Mild cigar differing in flavour (apple, cream, original and wine). Participants are single-blinded to cigar flavours. Each session consists of two 10-puff smoking bouts (30 s interpuff interval) separated by 1 hour. Primary outcomes include saliva nicotine concentration, behavioural economic task performance and response to various questionnaire items assessing subjective effects predictive of abuse liability. Differences in outcomes across own brand cigarette and flavoured cigar conditions will be tested using linear mixed models.
The Virginia Commonwealth University Institutional Review Board approved the study (VCU IRB: HM20007848). Dissemination channels for study findings include scientific journals, scientific meetings, and policy briefs.
NCT02937051.
在美国，食品药品监督管理局的规定禁止销售调味香烟，但薄荷醇香烟除外。然而，调味雪茄产品的制造、广告和销售是被允许的。此类调味剂会影响对烟草产品的积极认知，并与烟草使用增加有关。调味剂可能会掩盖烟草的味道并增强烟雾吸入，从而影响新手烟草使用者的毒物暴露和成瘾可能性。本研究采用临床实验室方法，调查调味剂的可得性如何影响年轻成年吸烟者的成瘾可能性指标。具体目标是评估雪茄调味剂对尼古丁暴露以及成瘾可能性的行为和主观指标的影响。
参与者（预计n = 25）为过去3个月每天吸食5支或更多香烟的健康吸烟者，年龄在18至25岁之间，未吸食过雪茄（终生吸食不超过50支雪茄产品，且过去30天内吸食不超过10支雪茄），且在未来30天内无意戒烟。参与者按照拉丁方设计完成五个实验室环节，使用他们自己品牌的香烟或特定环节的不同口味（苹果味、奶油味、原味和酒味）的Black & Mild雪茄。参与者对雪茄口味单盲。每个环节包括两次10口的吸烟过程（每口间隔30秒），中间间隔1小时。主要结果包括唾液尼古丁浓度、行为经济学任务表现以及对评估成瘾可能性预测主观效应的各种问卷项目的反应。将使用线性混合模型测试自有品牌香烟和调味雪茄条件下结果的差异。
弗吉尼亚联邦大学机构审查委员会批准了该研究（VCU IRB：HM20007848）。研究结果的传播渠道包括科学期刊、科学会议和政策简报。
NCT02937051。
