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Biochemical estimation of noncompliance with smoking of very low nicotine content cigarettes.

ABSTRACT: The 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.Data 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.The 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.Biomarker analysis demonstrates a high degree of noncompliance with smoking VLNC cigarettes, indicating that smokers are supplementing these with conventional cigarettes.We propose a practical approach to assessing compliance with smoking VLNC in clinical trials of nicotine reduction.

SUBMITTER: Benowitz NL

PROVIDER: S-EPMC4323626 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Biochemical estimation of noncompliance with smoking of very low nicotine content cigarettes.

Benowitz Neal L NL Nardone Natalie N Hatsukami Dorothy K DK Donny Eric C EC

Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 20141121 2

<h4>Background</h4>The 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 non ...[more]

PMID: 25416718

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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).

Project description:IntroductionSmoking to reduce negative affect has been identified as a key motivational feature of tobacco use. Our recent work suggests that smoking very low nicotine content (VLNC) cigarettes reduces the relationship between negative affect and smoking behavior over a 6-week period. Here, we sought to extend our findings by evaluating whether a gradual or immediate approach to switching to VLNC cigarettes led to a differential reduction in the relationship between affect and smoking behavior over a longer (20-week) period.Aims and methodsParticipants (n = 1250) were adult smokers from 10 US sites randomized to one of three groups: gradual nicotine reduction (15.5, 11.7, 5.2, 2.4, and 0.4 mg of nicotine per gram of tobacco [mg/g]), immediate nicotine reduction (0.4 mg/g), or standard nicotine content cigarettes (15.5 mg/g; control), for 20 weeks. We examined whether the relationship between affect-both negative and positive-and cigarettes per day differed as a function of reduction group.ResultsWe found that both negative and positive affect were associated with cigarette consumption in the control group, but not in the gradual or immediate reduction groups across the 20 weeks of exposure.ConclusionsOur results extend previous findings that switching to VLNC cigarettes disrupts the relationship between affect and cigarette consumption by showing that either gradually or immediately reducing cigarette nicotine content achieves this disruption. These findings provide further evidence that switching to VLNC cigarettes reduces nicotine-related reinforcement of cigarette smoking.ImplicationsThese findings support the notion that switching to very low nicotine content cigarettes reduces the association between affect and smoking behavior, and that either a gradual or immediate nicotine reduction approach achieves this reduction. This provides further evidence that switching to very low nicotine content cigarettes weakens reinforcement mechanisms associated with nicotine dependence.

Project description:IntroductionMany people incorrectly think that very low nicotine content (VLNC) cigarettes are less carcinogenic than current cigarettes. This risk misperception by people who smoke could reduce motivation to quit under a nicotine reduction policy. We qualitatively examined perspectives on campaign messages designed to reduce misperceptions.Aims and methodsAdults who smoke from North Carolina participated in online interviews. After being introduced to the idea of a VLNC policy, participants were shown VLNC messages and asked about their perceptions on the clarity, understandability, persuasiveness, and meaning of the messages. We conducted a thematic content analysis of the transcripts.ResultsThirty adults who smoke cigarettes participated (15 females, 13 males, 2 nonbinary) with a mean age of 43 years. Central themes that emerged were: (1) Confusion about the proposed VLNC cigarette policy affected how messages were interpreted; (2) Messages that promote self-efficacy for quitting rather than guilt or fear were better received; and (3) Direct and succinct messages were seen as more able to grab attention and inform people who smoke. Some participant concerns focused on whether VLNC cigarettes would relieve their nicotine cravings and whether they would need to smoke more VLNC cigarettes to feel satisfied.ConclusionCampaign messages to educate the public about the harmful effects of smoking VLNC cigarettes may be more effective if people who smoke are informed about the policy's rationale to understand why nicotine is removed rather than the other harmful chemicals. Messages should also acknowledge the difficulty of quitting and be short and direct to capture attention.ImplicationsAdults who smoke have some confusion about nicotine reduction in cigarettes and this affects how they perceive potential communication campaign messages about the risk of smoking VLNC cigarettes. In our qualitative research, we found that adults who smoke prefer messages about VLNC cigarettes that acknowledge the challenge of quitting and that are direct and succinct. With further development, campaign messages may be able to reduce misperceptions about VLNC cigarettes and maximize the public health benefit of a nicotine reduction policy.

Project description:IntroductionBecause 30% of cigarettes sold in the United States are characterized as menthol cigarettes, it is important to understand how menthol preference may affect the impact of a nicotine reduction policy.MethodsIn a recent trial, non-treatment-seeking smokers were randomly assigned to receive very low nicotine cigarettes (VLNC; 0.4 mg nicotine/g tobacco) or normal nicotine cigarettes (NNC; 15.5 mg/g) for 20 weeks. On the basis of preference, participants received menthol or non-menthol cigarettes. We conducted multivariable regression analyses to examine whether menthol preference moderated the effects of nicotine content on cigarettes per day (CPD), breath carbon monoxide (CO), urinary total nicotine equivalents (TNE), urinary 2-cyanoethylmercapturic acid (CEMA), and abstinence.ResultsAt baseline, menthol smokers (n = 346) reported smoking fewer CPD (14.9 vs. 19.2) and had lower TNE (52.8 vs. 71.6 nmol/mg) and CO (17.7 vs. 20.5 ppm) levels than non-menthol smokers (n = 406; ps < .05). At week 20, significant interactions indicated that menthol smokers had smaller treatment effects than non-menthol smokers for CPD (-6.4 vs. -9.3), TNE (ratio of geometric means, 0.22 vs. 0.10) and CEMA (ratio, 0.56 vs. 0.37; ps < .05), and trended toward a smaller treatment effect for CO (-4.5 vs. -7.3 ppm; p = .06). Odds ratios for abstinence at week 20 were 1.88 (95% confidence interval [CI] = 0.8 to 4.4) for menthol and 9.11 (95% CI = 3.3 to 25.2) for non-menthol VLNC smokers (p = .02) relative to the NNC condition.ConclusionsAlthough menthol smokers experienced reductions in smoking, toxicant exposure, and increases in quitting when using VLNC cigarettes, the magnitude of change was smaller than that observed for non-menthol smokers.ImplicationsResults of this analysis suggest that smokers of menthol cigarettes may respond to a nicotine reduction policy with smaller reductions in smoking rates and toxicant exposure than would smokers of non-menthol cigarettes.

Project description:SignificanceThe US Food and Drug Administration (FDA) is considering a very low nicotine content (VLNC) product standard to substantially reduce nicotine in cigarettes. We examined whether learning about a potential VLNC standard increased smokers' interest in illicit purchases of cigarettes with regular nicotine content if such a standard were adopted.MethodsParticipants were a national convenience sample of 1712 US adult smokers. In an online experiment, we randomly assigned smokers to view information about a new VLNC standard (experimental condition) or no information (control condition). The experimental condition explained that a VLNC standard would remove 95% of the nicotine in cigarettes and would require stores to only sell VLNC cigarettes. Then, the survey assessed smokers' interest in purchasing regular cigarettes from three illicit sources.ResultsSmokers who learned about the VLNC standard were more likely to be very or extremely interested in purchasing regular cigarettes illicitly from a Web site compared to smokers in the control group (24% vs. 16%, p < .001). They were also more interested in illicitly buying cigarettes from a street vendor (19% vs. 13%, p < .001) and a store on an Indian reservation (28% vs. 22%, p < .05), compared to the control. The impact of learning about the VLNC standard on interest in illicit purchases did not differ by smoking frequency or current e-cigarette use.ConclusionsA VLNC standard could increase smokers' interest in illicit purchases of regular nicotine cigarettes. To prevent VLNC-induced illicit trade from undermining public health, FDA should consider proven measures such as track and trace for these products.ImplicationsLittle is known about how a VLNC cigarette standard would affect consumer interest in regular content cigarettes purchased from illicit sources (eg, the Internet). We found that smokers informed about a potential VLNC product standard had greater interest in illicit cigarette purchases, compared to controls. This suggests the importance of proactive measures accompanying a VLNC standard, such as track-and-trace cigarette packaging regulations and communication campaigns, in order to maximize the standard's public health impact.

Project description:IntroductionThe US Food and Drug Administration is considering implementing a reduced-nicotine standard for cigarettes. Given the high rate of smoking among people with serious mental illness (SMI), it is important to examine the responses of these smokers to very low nicotine content (VLNC) cigarettes.MethodsThis trial compared the effects of VLNC (0.4 mg nicotine/g tobacco) and normal nicotine content cigarettes (15.8 mg/g) over a 6-week period in non-treatment-seeking smokers with schizophrenia, schizoaffective disorder, or bipolar disorder (n = 58). Linear regression was used to examine the effects of cigarette condition on cigarettes per day, subjective responses, nicotine and tobacco toxicant exposure, craving, withdrawal symptoms, and psychiatric symptoms.ResultsAt week 6, participants in the VLNC condition smoked fewer cigarettes per day, had lower breath carbon monoxide levels, lower craving scores, and rated their study cigarettes lower in satisfaction, reward, enjoyment, and craving reduction than those in the normal nicotine content condition (ps < .05). Week 6 psychiatric and extrapyramidal symptoms did not differ by condition, except for scores on a measure of parkinsonism, which were lower in the VLNC condition (p < .05). There were no differences across conditions on total nicotine exposure, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, withdrawal symptoms, or responses to abstinence.ConclusionsThese results suggest that a reduced-nicotine standard for cigarettes would reduce smoking among smokers with SMI. However, the lack of effect on total nicotine exposure indicates VLNC noncompliance, suggesting that smokers with SMI may respond to a reduced-nicotine standard by substituting alternative forms of nicotine.ImplicationsResults from this trial suggest that a reduced-nicotine standard for cigarettes would reduce smoking rates and smoke exposure in smokers with SMI, without increasing psychiatric symptoms. However, noncompliance with VLNC cigarettes was observed, suggesting that these smokers might respond to a reduced-nicotine standard by substituting alternative forms of nicotine.

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Biochemical estimation of noncompliance with smoking of very low nicotine content cigarettes.

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Biochemical estimation of noncompliance with smoking of very low nicotine content cigarettes.

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