NEW STUDY: Comparison between Gradual Reduced Nicotine Content and Usual Nicotine Content Groups on Subjective Cigarette Ratings in a Randomized Double-Blind Trial

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Abstract

In 2018, the United States Food and Drug Administration (FDA) issued an advanced notice of proposed rulemaking to reduce nicotine in tobacco products to produce a minimally addictive or nonaddictive effect, but there was a research gap in the subjective responses of reduced-nicotine-content cigarettes. We compared the responses of the modified cigarette evaluation questionnaire (mCEQ) and cigarette-liking scale (CLS) between the gradually reduced nicotine content (RNC) group and the usual nicotine content (UNC) group. Linear mixed-effects models for repeated measures were used to analyze and compare the change over time for the mCEQ and CLS across the two treatment groups (RNC and UNC). We found that the change over time for the mCEQ and CLS was significant between the RNC and the UNC treatment groups at the beginning of visit 6 with 1.4 mg nicotine/cigarette. At visits 8 and 9, the RNC group reported significantly lower satisfaction scores compared to UNC. Subscale analysis showed that smoking satisfaction decreased in RNC while other measures, such as cigarette enjoyment, did not change. Understanding the impact of nicotine reduction on cigarette subjective responses through evaluation and liking scales would provide valuable information to the FDA on nicotine reduction policies for cigarettes.
Keywords: reduced nicotine content; usual nicotine content; modified cigarette evaluation questionnaire; cigarette-liking scale

1. Introduction

Cigarette smoking in the United States (U.S.) has decreased from 42.4% in 1964 to 13.7% in 2018; nonetheless, cigarette smoking remains the primary preventable cause of death in the U.S., being responsible for more than 480,000 annual deaths [1,2,3]. Although smoking-related diseases are caused by chemicals in tobacco or created during the combustion process, nicotine is responsible for the addiction [3]. Prior research and literature demonstrated that a low-nicotine product standard for cigarettes could positively affect public health, specifically, implementation of a nicotine reduction policy could prevent 16 million people from smoking by 2060 and prevent approximately 8.5 million tobacco-related deaths in the United States by 2100 [4]. The U.S. Food and Drug Administration (FDA) issued an Advanced Notice of Proposed Rulemaking (ANPRM) in 2018 to reduce nicotine in tobacco products to make them minimally addictive or nonaddictive [5]. Clinical studies have indicated the benefit of very low nicotine content (VLNC) in the reduction of nicotine exposure levels, biomarkers of smoke toxicant exposure, lower dependence, fewer cigarettes smoked per day, and increased quit attempts [6,7,8,9,10,11,12].
One consideration is the impact of the method of nicotine reduction (gradual vs. immediate) in cigarettes [13]. Although an immediate transition to VLNC cigarettes in a recent study by Hatsukami et al. resulted in better health outcomes [8], it led to a higher rate of participant attrition and lower compliance compared to gradual reduction [8]. The method of nicotine reduction is an important factor. Immediate reduction may offer less harmful exposure overall, but gradual reduction may garner more support and compliance from smokers.
Subjective measures are important tools for measuring the acceptability and sensory effects of low nicotine products. Acceptability may modify the behavioral responses to reduced nicotine products used in trials, such as participant compliance and dropout. This could foreshadow the population-level response to a reduced nicotine policy. A secondary analysis in the Hatuskami et al. trial found that the immediate nicotine reduction group scored significantly lower than the gradual reduction group on multiple subscales of the modified cigarette evaluation questionnaire (mCEQ), which measures both positive and negative reinforcements of smoking [13]. Other studies have examined cigarette characteristics (such as taste and draw) by measuring the subjective effects of smoking, recognizing that nicotine alone is not the only contributor to the smoking experience [14].
As a national nicotine reduction policy has yet to be administered, it is still important and necessary to explore the gradual reduction method. Few studies compared the multiple factors of the smoking experience between the gradually reduced nicotine content (RNC) cigarettes and usual nicotine content (UNC) cigarettes in a randomized controlled trial. We aimed to study and compare the change over time using the mCEQ [15] and the cigarette-liking scale (CLS) [14] across two treatment groups (RNC and UNC). This study included a study population of low socioeconomic status (SES) smokers. Unique subpopulations, such as low SES smokers, have higher levels of nicotine dependence and increased smoking rates, which may cause different experiences with reduced nicotine cigarettes, such as higher aversions and lower acceptability scores.
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on Thu, 10/01/2020 - 19:28   admin
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