Dataset Information

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

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.

SUBMITTER: Lin W

PROVIDER: S-EPMC7579069 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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

Lin Wenxue W Krebs Nicolle M NM Zhu Junjia J Foulds Jonathan J Horn Kimberly K Muscat Joshua E JE

International journal of environmental research and public health 20200926 19

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 nicoti ...[more]

PMID: 32993116

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Project description:BackgroundA recent clinical trial showed that an immediate transition to very low nicotine content (VLNC) cigarettes, compared with a gradual transition, produced greater reductions in smoking behavior, smoke exposure, and dependence. However, there was less compliance with the instruction to smoke only VLNC cigarettes in the immediate versus gradual reduction condition. The goal of this study was to test whether nicotine reduction method alters subjective ratings of VLNC cigarettes, and whether subjective ratings mediate effects of nicotine reduction method on smoking behavior, smoke exposure, dependence, and compliance.MethodsThis is a secondary analysis of a randomized trial conducted across 10 sites in the United States. Smokers (n = 1250) were randomized to either a control condition, or to have the nicotine content of their cigarettes reduced immediately or gradually to 0.04 mg nicotine/g of tobacco during a 20-week study period. Participants completed the modified Cigarette Evaluation Questionnaire (mCEQ).ResultsAfter Week 20, the immediate reduction group scored significantly lower than the gradual reduction group on multiple subscales of the mCEQ (ps < .001). The Satisfaction subscale of the mCEQ mediated the impact of nicotine reduction method on smoke exposure, smoking behavior, dependence, compliance, and abstinence. Other subscales also mediated a subset of these outcomes.ConclusionsAn immediate reduction in nicotine content resulted in lower product satisfaction than a gradual reduction, suggesting that immediate reduction further reduces cigarette reward value. This study will provide the Food and Drug Administration with information about the impact of nicotine reduction method on cigarette reward value.ImplicationsThese data suggest that an immediate reduction in nicotine content will result in greater reductions in cigarette satisfaction than a gradual reduction, and this reduction in satisfaction is related to changes in smoking behavior and dependence.

Project description:ImportanceThe US Food and Drug Administration is considering limiting cigarettes to very low nicotine levels. Cigarette consumption of nondaily intermittent smokers (ITS), who compose one-third of US adult smokers, could feasibly increase or could be unaffected if their smoking is not motivated by nicotine seeking.ObjectiveTo compare cigarette consumption in ITS receiving very low-nicotine-content cigarettes (VLNCCs) or identical normal-nicotine-content cigarettes (NNCCs).Design, setting, and participantsThis randomized double-blind clinical trial was conducted from June 2015 to July 2017 at a single US site. Volunteer ITS not planning to quit were recruited via media. Overall, 297 individuals enrolled, and 238 were randomized. Analyses were intent-to-treat.InterventionsAfter a 2-week baseline of smoking their own brand of cigarettes provided gratis, ITS were randomized to VLNCCs or NNCCs for 10 weeks.Main outcomes and measuresThe number of cigarettes per day (CPD) was assessed by real-time reporting, timeline follow-back reports, and cigarette butt counts. The primary outcome was change in CPD from baseline to weeks 9 to 10 of intervention, adjusting for baseline CPD.ResultsThe mean (SD) age of the 238 randomized participants was 37.9 (13.8) years. Of 238 participants, 108 (45%) were men. At baseline, the mean (SD) CPD was 3.1 (2.9). In intent-to-treat analyses using multiple imputation to address missing data, the VLNCC group had a mean decrease of 1.6 CPD (95% CI, 1.1-2.0; 51% of baseline) vs 0.05 decrease with NNCCs (95% CI, -0.5 to 0.4; 2% of baseline). Treatment group differences were not materially moderated by sex, race/ethnicity, or history of daily smoking. Cheating with conventional cigarettes, inferred from cotinine assays, was more common in the VLNCC group (OR, 2.95; 95% CI, 1.54-5.66), but sensitivity analyses showed significant VLNCC effects among the compliant participants as well. In longitudinal analysis of CPD over time with random intercept and slope, the VLNCC and NNCC groups differed significantly in both linear (-0.15; 95% CI, -0.22 to -0.08; P < .001) and quadratic (0.0026; 95% CI, 0.0010-0.0042; P = .002) trends: CPD dropped by 43.8% in the VLNCC group over 4 weeks, then leveled off thereafter. Abstinence (intent-to-treat, biochemically verified) in weeks 9 to 10 postrandomization did not differ significantly by treatment group (VLNCC, 10.2% vs NNNC, 5.0%; P = .28).Conclusions and relevanceSwitching to VLNCCs caused substantial smoking reduction among ITS but did not significantly increase abstinence. Response to a VLNCC intervention suggests that nicotine-seeking motivates ITS' smoking.Trial registrationClinicalTrials.gov Identifier: NCT02228824.

Project description:IntroductionGiven FDA's authority to implement a cigarette nicotine reduction policy, possible outcomes of this regulation must be examined, especially among those who may be most affected, such as those with comorbid psychiatric disorders.MethodsIn this secondary analysis of a multisite, randomized, clinical laboratory study, we used analyses of variance to examine the effects of nicotine dose (0.4, 2.4, 5.2, and 15.8 mg/g of tobacco), depressive and anxiety diagnoses (depression only, anxiety only, both, or neither), and depressive and anxiety symptom severity on cigarette choice, smoke exposure, craving, and withdrawal across three vulnerable populations: socioeconomically disadvantaged women of reproductive age, opioid-dependent individuals, and those with affective disorders (n = 169).ResultsDiagnosis and symptom severity largely had no effects on smoking choice, total puff volume, or CO boost. Significant main effects on craving and withdrawal were observed, with higher scores in those with both anxiety and depression diagnoses compared with depression alone or no diagnosis, and in those with more severe depressive symptoms (p's < .001). These factors did not interact with nicotine dose. Cigarettes with <15.8 mg/g nicotine were less reinforcing, decreased total puff volume, and produced significant but lower magnitude and shorter duration reductions in craving and withdrawal than higher doses (p's < .01).ConclusionsReducing nicotine dose reduced measures of cigarette addiction potential, with little evidence of moderation by either psychiatric diagnosis or symptom severity, providing evidence that those with comorbid psychiatric disorders would respond to a nicotine reduction policy similarly to other smokers.ImplicationsThus far, controlled studies in healthy populations of smokers have demonstrated that use of very low nicotine content cigarettes reduces cigarette use and dependence without resulting in compensatory smoking. These analyses extend those findings to a vulnerable population of interest, those with comorbid psychiatric disorders. Cigarettes with very low nicotine content were less reinforcing, decreased total puff volume, and produced significant but lower magnitude and shorter duration reductions in craving and withdrawal than higher doses. These nicotine dose effects did not interact with psychiatric diagnosis or mood symptom severity suggesting that smokers in this vulnerable population would respond to a nicotine reduction strategy similarly to other smokers.

Dataset Information

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

Publications

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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