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Reasons for Non-compliance in a Trial of Reduced Nicotine Cigarettes

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Objectives: In this paper, we examine the rates of, and reasons for self-reported non-compliance in a reduced-nicotine cigarette (RNC) clinical trial. Methods: We conducted a secondary analysis of a double-blind, parallel, clinical trial randomizing 839 smokers for 6-weeks to smoke their usual brand or investigational cigarettes ranging from 15.8 mg nicotine/g tobacco (control) to 0.4 mg/g (RNCs). We measured non-compliance, ie, self-reported smoking of non-study cigarettes, on a daily basis. Overall, 252 participants (30%) completed a survey assessing reasons for non-compliance. Results: Most participants (68%) reported non-compliance. Smokers receiving RNCs self-reported higher rates of non-compliance ranging from 77% (66%, 86%) to 82% (65%, 93%), than smokers in the control group; 50% (32%, 68%). Self-reported non-compliance decreased with time in the study (52% at Week 1 to 35% at Week 6). The most endorsed situation for non-compliance was the first cigarette of the day (47% of all participants). Older (greater than 44 years) and more nicotine-dependent individuals were more likely to report non-compliance with the first cigarette of the day and after a meal. Conclusions: Our results support the importance of nicotine-seeking in non-compliance. Individuals were most likely to be non-compliant in situations when deprived of nicotine.
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Keywords: CLINICAL TRIAL; NON-COMPLIANCE; REDUCED NICOTINE; SELF-REPORT

Document Type: Research Article

Publication date: January 1, 2019

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  • Tobacco Regulatory Science (Electronic ISSN 2333-9748) is a rigorously peer-reviewed online scientific journal for the dissemination of research relevant to the regulation of tobacco products. The journal content includes a broad array of research domains, including chemistry, biology, behavior, community, and population-level surveillance and epidemiology, as well as knowledge syntheses (eg, meta-analyses or state-of-the-art reviews) and analytic modeling. All articles describe the policy relevance of the research outcomes. Given the global nature of tobacco regulation, particularly as a result of international and national policies, Tobacco Regulatory Science publishes high quality research that is relevant to global regulatory needs and requirements. Tobacco Regulatory Science is published electronically 6 times per year.
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