Triangulating abuse liability assessment for flavoured cigar products using physiological, behavioural economic and subjective assessments: a within-subjects clinical laboratory protocol

Catherine S Wall, Rose S Bono, Rebecca C Lester, Cosima Hoetger, Thokozeni Lipato, Mignonne C Guy, Thomas E Eissenberg, Warren K Bickel, Andrew J Barnes, Caroline O Cobb, Catherine S Wall, Rose S Bono, Rebecca C Lester, Cosima Hoetger, Thokozeni Lipato, Mignonne C Guy, Thomas E Eissenberg, Warren K Bickel, Andrew J Barnes, Caroline O Cobb

Abstract

Introduction: 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.

Methods and analyses: 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.

Ethics and dissemination: 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.

Trial registration number: NCT02937051.

Keywords: abuse liability; cigars; flavor; protocol; regulatory science; tobacco.

Conflict of interest statement

Competing interests: TEE is a paid consultant in litigation against the tobacco industry and is named on a patent application for a device that measures the puffing behaviour of electronic cigarette users.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Session timeline in minutes. *, 10 puffs of session product administered; B, behavioural measures administered; CO, expired air CO measured; End, physiological monitoring ends; Phys, physiological monitoring begins and mouth rinse; S, subjective measures administered; Sal, saliva collection.

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