Risk Perceptions of Low Nicotine Cigarettes and Alternative Nicotine Products across Priority Smoking Populations.
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ABSTRACT:
SUBMITTER: Denlinger-Apte RL
PROVIDER: S-EPMC8156883 | biostudies-literature | 2021 May
REPOSITORIES: biostudies-literature
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Risk Perceptions of Low Nicotine Cigarettes and Alternative Nicotine Products across Priority Smoking Populations.
Denlinger-Apte Rachel L RL Pacek Lauren R LR Ross Jennifer Cornacchione JC Bansal-Travers Maansi M Donny Eric C EC Hatsukami Dorothy K DK Carroll Dana Mowls DM
International journal of environmental research and public health 20210517 10
<h4>Background</h4>As the U.S. Food and Drug Administration considers a low nicotine product standard for cigarettes, it is important to examine how people who smoke, especially individuals from priority populations disproportionately affected by smoking, perceive low nicotine content (LNC) cigarettes and their relative risk perceptions of alternative nicotine delivery system (ANDS) products, including e-cigarettes and snus, and medicinal nicotine.<h4>Methods</h4>Data are from Wave 4 (2016-2017) ...[more]
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Project description:There has been long-standing interest in a reduced-nicotine product standard for combusted tobacco, which is within the regulatory purview of the Food and Drug Administration (FDA). In weighing whether to establish this standard, it is important to consider potential responses among people who are at elevated risk for tobacco-related health harms. In this narrative review, we summarize studies of very low nicotine content (VLNC) cigarettes conducted between 2010 and 2021 in groups that the FDA has identified as vulnerable populations. Studies conducted to date in adults with mental health conditions, adults with opioid use disorder, socioeconomically-disadvantaged adults, and youth or young adults indicate that immediate switching to VLNC cigarettes decreases smoking, with minimal or no unintended negative consequences. Few studies have investigated the effects of VLNC cigarettes in racial or ethnic minorities, people who smoke menthol cigarettes, and pregnant women, but initial findings suggest that responses of these individuals are similar to responses observed in other vulnerable populations. We are not aware of studies that have investigated VLNC cigarettes in military/veteran populations, sexual or gender minority individuals, or people living in underserved rural environments. Future research directions include understanding how to promote cessation in the context of a reduced-nicotine standard, and how to correct VLNC misperceptions in vulnerable populations. Nevertheless, the evidence to date indicates that a reduced-nicotine standard is likely to have the same beneficial effects on smoking reductions as it does in less vulnerable populations, which should provide some confidence in pursuing this regulatory approach.
| S-EPMC9699899 | biostudies-literature
Project description:AimsTo compare the use of alternative nicotine products, smoking behavior and tobacco biomarker exposure in smokers unwilling to quit who were assigned randomly to normal nicotine content (NNC) cigarettes or very low nicotine content (VLNC) cigarettes.DesignRandomized, parallel-arm 8-week study with assignment to VLNC (VLNC 1, n = 53) or NNC (NNC, n = 27) with access to non-cigarette combusted and non-combusted tobacco/nicotine products or to VLNC with access to only non-combusted products (VLNC2, n = 56).SettingClinics in Minnesota, USA.ParticipantsSmokers uninterested in quitting smoking with a mean [± standard deviation (SD)] age of 44 (± 14) years and smoking 16 (± seven) cigarettes/day; 51% female, 72% white.MeasurementsDuring the experimental period, the measures taken included: rate of alternative products used, amount of and abstinence from combusted tobacco used and tobacco exposure biomarkers.FindingsThere were higher rates of non-combusted alternative tobacco/nicotine product use in both VLNC conditions versus the NNC condition [rate ratio (RR) = 2.18, 95% confidence interval (CI) = 1.94, 2.46 and RR = 1.64, 95% CI = 1.46, 1.85, respectively] and in VLNC1 versus VLNC2 condition (RR = 1.33, 95% CI = 1.23, 1.44), accompanied by reduced biomarkers of exposure primarily in VLNC2 condition compared to NNC condition (Ps < 0.05). Fewer combusted products were smoked at almost all visits (Ps ≤ 0.02) and there were higher rates of abstinence for both VLNC conditions compared with the NNC condition (VLNC1 versus NNC: RR = 9.96, 95% CI = 5.01, 19.81; VLNC2 versus NNC: RR = 11.23, 95% CI = 5.74, 21.97).ConclusionThe offer of, and instructions to use, reduced nicotine content cigarettes during an 8-week period led to greater use of alternative tobacco/nicotine products compared with continued use of normal nicotine cigarettes and also reductions in smoking rates.
| S-EPMC5249662 | biostudies-literature
Project description:IntroductionThe electronic cigarette (e-cigarette) market has evolved rapidly in recent years, with exploding growth in brands and product types; however, e-cigarette use among priority (sexual minority and low-income) populations and its relationship with smoking-cessation and tobacco control policies have yet to be fully characterized.MethodsThe authors conducted a nationally representative online survey of 17,522 U.S. adults in 2013. Participants were drawn from GfK's KnowledgePanel. Logistic regression models were used to analyze relationships between e-cigarettes (awareness, ever use, current use) and cigarette smoking and cessation behaviors, tobacco control policies, and demographics. Analyses were conducted in 2014.ResultsApproximately 15% of participants reported ever use of e-cigarettes, 5.1% reported current use, and 34.5% of ever users reported current use. E-cigarette awareness was lower among women, minorities, and those with low education. Ever and current use of e-cigarettes was higher among current cigarette smokers, young adults, and those with low SES; both ever use and current use were correlated with current cigarette smoking status, particularly when combined with quit intentions or attempts. Lesbian/gay/bisexual/transgender respondents had higher rates of ever use and current use. Ever use was lower in states with comprehensive smoking bans. No significant relationship between cigarette price and e-cigarette use was detected.ConclusionsOngoing surveillance of e-cigarette use among subpopulation groups and monitoring their use for combustible cigarette cessation are needed. Important variations in the patterns and correlates of e-cigarette awareness and use exist among priority populations. These findings have implications for future e-cigarette policy decisions.
| S-EPMC4718827 | biostudies-literature
Project description:Background and aimsE-cigarettes (EC) and nicotine replacement therapy (NRT) are less harmful than smoking, but misperceptions of relative harm are common. Aims were to (1) assess nicotine knowledge and perceptions of: harm of EC and NRT relative to smoking, addictiveness of EC relative to smoking, and change in harm to user if smoking replaced with EC; (2) define associations of these perceptions with respondent characteristics including nicotine knowledge; and (3) explore perceived main harms of EC and whether these differ by vaping status.DesignAnalyses were: (1) frequencies; (2) logistic regressions of perceptions of relative harm, addictiveness and change in harm onto demographics, smoking and vaping status and nicotine knowledge (attributing cancer or health risks of smoking to nicotine); and (3) frequencies and χ2 statistics.Setting and participantsParticipants were smokers and recent ex-smokers from one wave (September 2017) of a longitudinal online survey in the United Kingdom (n = 1720).MeasurementsDemographics included gender, age, smoking status, vaping status and income. Survey questions collected data on nicotine knowledge and harm perceptions of different products; the relative harm perceptions of NRT, EC and tobacco cigarettes; and perceived main harms of EC.FindingsRelative to smoking, 57.3% perceived EC and 63.4% NRT to be less harmful; 25.4% perceived EC to be less addictive; and 32.2% thought replacing smoking with EC reduced health harms a great deal. Participants were less likely to endorse these beliefs if they had never vaped, and participants who had inaccurate nicotine knowledge were less likely to endorse all these beliefs apart from the addictiveness of EC. The main concerns about EC were a lack of research (48.3%), regulation or quality control (37.8%) and harmfulness of chemicals (41.6%).ConclusionsLarge proportions of UK smokers and ex-smokers overestimate the relative harmfulness of e-cigarettes and nicotine replacement therapy compared with smoking; misattributing smoking harms to nicotine is associated with increased misperceptions.
| S-EPMC6491935 | biostudies-literature
Project description:BackgroundThe reduction of the nicotine content of cigarettes to nonaddicting levels is a potential federal regulatory intervention to reduce the prevalence of cigarette smoking and related disease. Many clinical trials on the effects and safety of nicotine reduction are ongoing. An important methodologic concern is noncompliance with reduced nicotine content cigarettes in the context of freely available conventional cigarettes. We propose two approaches using biomarkers to estimate noncompliance in smokers of very low nicotine content (VLNC) cigarettes in a clinical trial.MethodsData from 50 subjects in a study of gradual nicotine reduction were analyzed. Using plasma cotinine concentrations measured at baseline and while smoking VLNC cigarettes, we compared within-subject ratios of plasma cotinine comparing usual brand to VLNC in relation to nicotine content of these cigarettes. In another approach, we used nicotine pharmacokinetic data to estimate absolute plasma cotinine/cigarettes per day (CPD) threshold values for compliance based on the nicotine content of VLNC.ResultsThe two approaches showed concordance, indicating at least 60% noncompliance with smoking VLNC. In a sensitivity analysis assuming extreme compensation and extreme values for nicotine metabolic parameters, noncompliance was still at least 40%, much higher than self-reported noncompliance.ConclusionBiomarker analysis demonstrates a high degree of noncompliance with smoking VLNC cigarettes, indicating that smokers are supplementing these with conventional cigarettes.ImpactWe propose a practical approach to assessing compliance with smoking VLNC in clinical trials of nicotine reduction.
| S-EPMC4323626 | biostudies-literature
Project description:BackgroundReducing the nicotine content in cigarettes could improve public health by reducing smoking and toxicant exposure, but may also have unintended consequences on alcohol use. The primary objective of this study was to examine the effect of reducing the nicotine content in cigarettes on alcohol outcomes. The secondary aim was to examine whether the effects of these cigarettes on alcohol outcomes were mediated by changes in nicotine exposure, smoking behavior, or withdrawal.MethodsBetween June 2013 and July 2014, we conducted a 7-arm, double-blind, randomized clinical trial at 10 U.S.-based sites. Daily smokers not currently interested in quitting (n = 839) were assigned to equally sized groups to smoke for 6 weeks cigarettes containing either normal nicotine content (NNC; 15.8 mg/g, 9 mg tar), moderate nicotine content (5.2 mg/g nicotine, 9 mg tar), or very low nicotine content (VLNC; 0.4 to 2.4 mg/g, 9 to 13 mg tar). This investigation focused on a subsample of current drinkers (n = 403). Each reduced nicotine content cigarette condition was compared to the NNC control condition with respect to trajectories over the 6-week period of average daily alcohol use and occurrence of binge drinking. Moderating variables were considered. Mediation analyses tested potential explanatory processes including changes in nicotine exposure, cigarettes per day, and withdrawal.ResultsOver time, reduced nicotine exposure and smoking rate mediated effects of VLNC cigarette use on reduced alcohol use. There was no evidence of compensatory drinking in response to nicotine reduction or nicotine withdrawal, even among subgroups expected to be at greater risk (e.g., relatively heavier drinkers, highly nicotine-dependent individuals).ConclusionsThe findings suggest that compensatory drinking is unlikely to occur in response to switching to VLNC cigarettes. In contrast, reducing the nicotine content of cigarettes may reduce alcohol use (clinicalTrials.gov number, NCT01681875).
| S-EPMC5347256 | biostudies-literature
Project description:ImportanceProhibiting the sale of commonly preferred e-cigarette flavors (eg, fruity and sweet) to discourage use among youths poses a risk of diminishing efforts to decrease smoking in adults.ObjectiveTo compare reductions in smoking achieved in adults with psychiatric conditions or lower educational level using very low nicotine content (VLNC) cigarettes alone, combined with e-cigarettes limited to tobacco flavor (TF), or combined with e-cigarettes in participant-preferred flavors.Design, setting, and participantsThree randomized clinical trials were conducted for 16 weeks from October 2020 through November 2023 at the University of Vermont, Brown University, and Johns Hopkins University. Participants were adults who smoked daily and were not planning to quit in the next 30 days. These participants were from 3 at-risk populations: those with affective disorders, exemplifying mental illness; those with opioid use disorder, exemplifying substance use disorders; and females of reproductive age with a high-school education or less, exemplifying lower educational level. Participants were randomly assigned to 1 of 4 experimental conditions: (1) normal nicotine content (NNC) cigarettes only; (2) VLNC cigarettes only; (3) VLNC cigarettes plus e-cigarettes with classic TF (hereafter, VLNC + TF); and (4) VLNC cigarettes plus e-cigarettes with preferred flavors (hereafter, VLNC + PF).InterventionsThe NNC cigarettes contained 15.8 mg nicotine/g tobacco, the VLNC cigarettes contained 0.4 mg nicotine/g tobacco, the VLNC + TF had pods containing 5% nicotine by weight and only classic TF, and the VLNC + PF had pods containing 5% nicotine in 8 flavors (including fruity and sweet) from which participants selected 3 flavors.Main outcomes and measuresThe primary outcome was mean total cigarettes smoked per day (CPD) during week 16. Tobacco-related biomarkers were assessed, including total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a tobacco-specific carcinogen.ResultsA total of 326 participants (mean [SD] age, 40.09 [10.79] years; 243 females [74.5%]) from 3 randomized clinical trials were included. The VLNC cigarettes decreased total CPD, with least square (LS) means (SEMs) of 22.54 (1.59) in the NNC, 14.32 (1.32) in the VLNC, 11.76 (1.18) in the VLNC + TF, and 7.63 (0.90) in the VLNC + PF conditions. Each VLNC condition differed significantly from NNC, with an adjusted mean difference (AMD) of -8.21 (95% CI, -12.27 to -4.16; P < .001) in the VLNC, -10.78 (95% CI, -14.67 to -6.90; P < .001) in the VLNC + TF, and -14.91 (95% CI, -18.49 to -11.33; P < .001) in the VLNC + PF conditions. Participants in the VLNC + PF condition also decreased smoking below the VLNC and the VLNC + TF conditions (AMDs, -6.70 [95% CI, -9.84 to -3.55; P < .001] and -4.13 [95% CI, -7.05 to -1.21; P = .02]); the VLNC and VLNC + TF conditions did not differ significantly. Consistent with decreases in CPD, NNAL levels in the VLNC + PF condition were lower than in all other conditions, with AMDs (in pmol/mg creatinine) of -0.94 (95% CI, -1.41 to -0.47; P < .001) compared with the NNC condition, -0.47 (95% CI, -0.87 to -0.08; P = .03) compared with the VLNC condition, and -0.46 (95% CI, -0.83 to -0.10; P = .04) compared with the VLNC + TF condition.Conclusions and relevanceThese results provide further evidence that a reduced-nicotine standard for cigarettes has the potential to decrease smoking and tobacco-toxicant exposure in high-risk populations and that these effects may be enhanced when adults can access e-cigarettes in commonly preferred flavors.Trial registrationClinicalTrials.gov Identifiers: NCT04092387, NCT04090879, NCT04092101.
| S-EPMC11380105 | biostudies-literature
Project description:BackgroundA mandated reduction in the nicotine content of cigarettes could reduce smoking rate and prevalence. However, one concern is that smokers may compensate by increasing the intensity with which they smoke each cigarette to obtain more nicotine. This study assessed whether smokers engage in compensatory smoking by estimating the mouth-level nicotine intake of low nicotine cigarettes smoked during a clinical trial.MethodsSmokers were randomly assigned to receive cigarettes with one of five nicotine contents for 6 weeks. An additional group received a cigarette with the lowest nicotine content, but an increased tar yield. The obtained mouth-level nicotine intake from discarded cigarette butts for a subset of participants (51-70/group) was estimated using solanesol as described previously. A compensation index was calculated for each group to estimate the proportion of nicotine per cigarette recovered through changes in smoking intensity.ResultsThere was no significant increase in smoking intensity for any of the reduced nicotine cigarettes as measured by the compensation index (an estimated 0.4% of the nicotine lost was recovered in the lowest nicotine group; 95% confidence interval, -0.1 to 1.2). There was a significant decrease in smoking intensity for very low nicotine content cigarettes with increased tar yield.ConclusionsReductions in nicotine content did not result in compensatory changes in how intensively participants smoked research cigarettes.ImpactCombined with data from clinical trials showing a reduction in cigarettes smoked per day, these data suggest that a reduction in nicotine content is unlikely to result in increased smoke exposure.
| S-EPMC7100998 | biostudies-literature
Project description:IntroductionWithin tobacco prevention programming, it is useful to identify youth that are at risk for experimenting with various tobacco products and e-cigarettes. The susceptibility to smoking construct is a simple method to identify never-smoking students that are less committed to remaining smoke-free. However, the predictive validity of this construct has not been tested within the Canadian context or for the use of other tobacco products and e-cigarettes.MethodsThis study used a large, longitudinal sample of secondary school students that reported never using tobacco cigarettes and noncurrent use of alternative tobacco products or e-cigarettes at baseline in Ontario, Canada. The sensitivity, specificity, and positive and negative predictive values of the susceptibility construct for predicting tobacco cigarette, e-cigarette, cigarillo or little cigar, cigar, hookah, and smokeless tobacco use 1 and 2 years after baseline measurement were calculated.ResultsAt baseline, 29.4% of the sample was susceptible to future tobacco product or e-cigarette use. The sensitivity of the construct ranged from 43.2% (smokeless tobacco) to 59.5% (tobacco cigarettes), the specificity ranged from 70.9% (smokeless tobacco) to 75.9% (tobacco cigarettes), and the positive predictive value ranged from 2.6% (smokeless tobacco) to 32.2% (tobacco cigarettes). Similar values were calculated for each measure of the susceptibility construct.ConclusionsA significant number of youth that did not currently use tobacco products or e-cigarettes at baseline reported using tobacco products and e-cigarettes over a 2-year follow-up period. The predictive validity of the susceptibility construct was high and the construct can be used to predict other tobacco product and e-cigarette use among youth.ImplicationsThis study presents the predictive validity of the susceptibility construct for the use of tobacco cigarettes among secondary school students in Ontario, Canada. It also presents a novel use of the susceptibility construct for predicting the use of e-cigarettes, cigarillos or little cigars, cigars, hookah, and smokeless tobacco among secondary school students in Ontario, Canada.
| S-EPMC6379029 | biostudies-literature
Project description:Background and aimsThe expense associated with using non-combustible nicotine products as an alternative to smoking may deter smoking reduction or cessation. This study aimed to estimate (i) how much adults in England spend each week on smoking and alternative nicotine products and (ii) the potential cost saving that could be achieved by switching from smoking to using an alternative nicotine delivery product.Design and settingData came from September to November 2018 waves of the Smoking Toolkit Study, a series of national household surveys of the adult population in England.ParticipantsA total of 859 adults (aged ≥ 16 years) who reported current smoking or current use of an alternative nicotine product.MeasurementsParticipants reported their average weekly expenditure on smoking and alternative nicotine products [nicotine replacement therapy (NRT) or e-cigarettes].FindingsCurrent smokers who did not use any alternative nicotine delivery products (n = 602) reported spending on average £23.09 [95% confidence interval (CI) = £21.64-24.54] on smoking each week. Ex-smokers who used alternative nicotine products (n = 91) reported spending on average £8.59 (95% CI = £6.80-10.39) on these products each week; £8.03 (95% CI = £6.03-10.03) on e-cigarettes and £10.05 (95% CI = £5.62-14.47) on NRT. People who both smoked and used alternative nicotine products (dual users, n = 166) spent on average £24.54 (95% CI = £21.78-27.29) on smoking and £7.49 (95% CI = £6.00-8.99) on alternative nicotine products each week. Expenditure on smoking was higher among heavier, more addicted smokers and lower among those with routine/manual occupations, non-daily smokers and roll-your-own tobacco users. Expenditure on e-cigarettes was higher among men, users from central and southern versus northern England and smokers who had tried to quit in the past year, and lower among current smokers. Expenditure on NRT was lower among roll-your-own tobacco users.ConclusionsIn England, expenditure among e-cigarette and nicotine replacement therapy users is approximately one-third of the expenditure of smokers. The average smoker may save an estimated £15.06 per week by switching completely to e-cigarettes or £13.04 per week by switching to nicotine replacement therapy, although this is likely to differ according to individual usage patterns.
| S-EPMC6797497 | biostudies-literature