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Correlates of support for a nicotine-reduction policy in smokers with 6-week exposure to very low nicotine cigarettes.

ABSTRACT: BACKGROUND:The US Food and Drug Administration recently issued an advanced notice of proposed rule-making for reducing the nicotine content in cigarettes to a minimally addictive level. Very little is known about whether use of very low nicotine content (VLNC) cigarettes affects support for a nicotine reduction policy. OBJECTIVE:This study examined the effects of using VLNC versus usual brand (UB) cigarettes on support for a nicotine reduction policy and determined whether participant characteristics and responses to VLNC cigarettes were associated with policy support. METHODS:Participants from a cigarette trial who were assigned to either 0.4?mg nicotine/g tobacco research cigarettes or their UB for 6?weeks were asked about their support for the policy. ?2 tests were used to compare support for the policy between cigarette conditions and logistic regression analyses were conducted to assess covariates associated with policy support. FINDINGS:Policy support did not differ by condition. After 6 weeks of using VLNC cigarettes, 50% of participants supported the policy, 26% opposed and 24% responded 'Don't Know'. Support was higher among those adherent to smoking only VLNC cigarettes (65%) compared with those who were non-adherent (44%). Older participants and those interested in quitting had increased odds of support. Cigarette satisfaction, perceived harm and perceived nicotine content were not significantly associated with support. CONCLUSIONS:Smoking VLNC cigarettes did not affect support for a nicotine reduction policy. Understanding predictors of policy support and opposition will help public health officials to maximise the public health acceptance and impact of this policy (ClinicalTrials.gov Identifier: NCT01681875 Post-Results).

SUBMITTER: Denlinger-Apte RL

PROVIDER: S-EPMC6482068 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Correlates of support for a nicotine-reduction policy in smokers with 6-week exposure to very low nicotine cigarettes.

Denlinger-Apte Rachel L RL Tidey Jennifer W JW Koopmeiners Joseph S JS Hatsukami Dorothy K DK Smith Tracy T TT Pacek Lauren R LR McClernon F Joseph FJ Donny Eric C EC

Tobacco control 20181101 3

<h4>Background</h4>The US Food and Drug Administration recently issued an advanced notice of proposed rule-making for reducing the nicotine content in cigarettes to a minimally addictive level. Very little is known about whether use of very low nicotine content (VLNC) cigarettes affects support for a nicotine reduction policy.<h4>Objective</h4>This study examined the effects of using VLNC versus usual brand (UB) cigarettes on support for a nicotine reduction policy and determined whether partici ...[more]

PMID: 30385649

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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.

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:BackgroundThe FDA recently acquired regulatory authority over tobacco products, leading to renewed interest in whether reducing the nicotine content of cigarettes would reduce tobacco dependence in the United States. Given the association between depressive symptoms and cigarette smoking, it is important to consider whether smokers with elevated depressive symptoms experience unique benefits or negative consequences of nicotine reduction.MethodsIn this secondary analysis of a randomized clinical trial that examined the effects of cigarettes varying in nicotine content over a 6-week period in non-treatment-seeking smokers, we used linear regression to examine whether baseline depressive symptom severity (scores on the Center for Epidemiologic Studies Depression Scale [CES-D]) moderated the effects of reduced-nicotine content (RNC) cigarettes, relative to normal-nicotine content (NNC) cigarettes, on smoking rates, depressive symptom severity, and related subjective and physiological measures.ResultsOf the 717 participants included in this analysis, 109 (15.2%) had CES-D scores ≥ 16, indicative of possible clinical depression. Relative to NNC cigarettes, RNC cigarettes reduced smoking rates, nicotine dependence, and cigarette craving, and these effects were not significantly moderated by baseline CES-D score. A significant interaction between baseline CES-D score and cigarette condition on week 6 CES-D score was observed (p < .05); among those with CES-D scores ≥ 16 at baseline, those assigned to RNC cigarettes had lower week 6 CES-D scores than those assigned to NNC cigarettes. Among those in the lowest nicotine content conditions, biochemically confirmed compliance with the RNC cigarettes was associated with an increase in CES-D score for those with baseline CES-D scores < 16 and no change in CES-D score for those with baseline CES-D scores ≥ 16.ConclusionsThese findings provide initial evidence that a reduced-nicotine standard for cigarettes may reduce smoking, without worsening depressive symptoms, among smokers with elevated depressive symptoms.ImplicationsThis secondary analysis of a recent clinical trial examined whether depressive symptom severity moderated the effects of reduced-nicotine cigarettes on smoking and depressive symptoms. Results indicate that, regardless of baseline depressive symptoms, participants randomized to reduced-nicotine cigarettes had lower smoking rates, nicotine intake, nicotine dependence, and craving at week 6 post-randomization than those assigned to normal-nicotine cigarettes. In participants with higher baseline depressive symptoms, those assigned to reduced-nicotine cigarettes had lower week 6 depressive symptoms than those assigned to normal-nicotine cigarettes. These results suggest that a nicotine reduction policy could have beneficial effects for smokers, regardless of depressive symptom severity.

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:Electronic cigarette (EC) use is growing dramatically with use highest among young adults and current smokers. One of the most common reasons for using ECs is interest in quitting or reducing cigarettes per day (CPD); however there are few randomized controlled trials (RCT) on the effect of ECs on smoking abstinence and reduction.We conducted a two-arm; double-blind RCT. Subjects were randomized to receive 3-weeks of either disposable 4.5% nicotine EC (intervention) or placebo EC. The primary outcome was self-reported reduction of at least 50% in the number of CPDs smoked at week 3 (end of treatment) compared to baseline. Study subjects (n = 99) were young adult (21-35), current smokers (smoked ? 10 CPDs) living in NYC.Compared with baseline, a significant reduction in CPDs was observed at both study time periods (1 and 3 weeks) for intervention (P < .001) and placebo (P < .001) groups. Between-group analyses showed significantly fewer CPDs in the intervention group compared to the placebo group at week 3 (P = .03), but not at any other follow-up periods. The logistic regression analysis showed that using a greater number of ECs, treatment condition and higher baseline readiness to quit were significantly associated with achieving at least 50% reduction in CPDs at the end of treatment.A diverse young adult sample of current everyday smokers, who were not ready to quit, was able to reduce smoking with the help of ECs. Further study is needed to establish the role of both placebo and nicotine containing ECs in increasing both reduction and subsequent cessation.Despite the critical need for well-designed clinical trials on the effect of ECs on cessation and cigarette reduction, the majority of studies have been observational or noncomparative intervention designs. Only three RCTs studying ECs as a cessation or reduction intervention have been published, and none were conducted in the United States. The current study adds knowledge to current literature on the feasibility of using ECs to aid smoking reduction among young smokers in US urban populations.

Project description:This randomized, partially single-blinded, 6-period crossover clinical study of adult smokers compared the nicotine pharmacokinetics, impacts on smoking urge and tolerability of various formulations of one brand of e-cigarettes with that of a tobacco cigarette.Five e-cigarettes with different e-liquid formulations containing 1.6 % and 2.4 % nicotine and a conventional tobacco cigarette were randomized among 24 subjects under two exposure sessions consisting of a 30-min controlled and a one-hour ad lib use period to assess plasma nicotine levels, impacts on smoking urge and adverse events. The 30-min controlled use session comprised an intensive use of the e-cigarettes with a total of 50 puffs taken every 30 s for comparison to a single conventional cigarette having a typical machine-measured nicotine yield (~0.8 mg). Ad lib product use conditions provided insight into more naturalistic product use behaviors and their accompanying smoking urge reductions. Adverse events (AEs) were assessed by the Principal Investigator.Significant (p?<?0.05) increases in plasma nicotine concentrations occurred within 10 min of controlled e-cigarette use and significant (p?<?0.001) reductions from baseline smoking urge were observed within 5 min. E-cigarette and cigarette nicotine plasma levels were comparable for up to one hour of use. After both sessions (90 min), nicotine exposure was the highest for the cigarette, with all e-cigarettes showing 23 % to 53 % lower plasma concentrations. During controlled use, peak reduction in smoking urge for e-cigs occurred later than for the cigarette. After completion of both sessions, significant smoking urge reduction persisted for most of the tested e-cigarettes, albeit at levels lower than that provided by the tobacco cigarette. Nicotine content, vehicle differences, and the presence of menthol did not significantly affect smoking urge reduction by the e-cigarettes. No subjects were discontinued due to AEs. The most frequently reported AEs events included cough, throat irritation, headache, and dizziness.Blood plasma nicotine levels obtained from short-term use of e-cigarettes containing 1.6 % and 2.4 % nicotine were significant, but lower than those of conventional tobacco cigarettes, yet the reduction in craving symptoms were broadly comparable. The types of AEs were consistent with other research studies of longer duration that have reported that use of e-cigarettes by adult smokers is well-tolerated.http://ClinicalTrials.gov identifier: NCT02210754 . Registered 8 August 2014.

Project description:Background and aimsIn 2017, the US Food and Drug Administration (FDA) proposed to reduce nicotine in cigarettes to minimally or non-addictive levels. This study qualitatively explored perceptions of nicotine and addiction, both independently and in response to messages communicating about nicotine reduction.DesignQualitative study using focus groups. Participants described their perceptions of nicotine and addiction and their responses to messages about the nicotine reduction.SettingAtlanta, GA and San Francisco, CA, USA. Semi-structured focus groups were conducted virtually in Spring 2020.ParticipantsExclusive smokers (n = 27), dual users (of cigarettes and electronic cigarettes) (n = 25), former smokers (n = 32) and young adult non-smokers (n = 31).MeasurementInductive thematic analysis of transcripts was conducted, and results were compared across smoking status groups.FindingsParticipants across all smoking status groups associated nicotine with tobacco products, but consistently misperceived that nicotine caused disease. Perceptions of addiction were largely negative and varied by smoking status. Experienced smokers (exclusive smokers, former smokers and dual users) differentiated tobacco use from other addictions and minimized their own experiences of addiction. Perceptions of addiction across experienced smokers included not only the chemical properties of nicotine, but also the behavioral aspects of tobacco use, including oral fixation, having a smoking routine and response to internal and external cues. In response to messages, many believed that removing the nicotine would not make cigarettes less addictive because of the multi-factorial nature of smoking addiction that includes non-pharmacological cues.ConclusionsPerceptions of nicotine and addiction among non-smokers, former smokers, exclusive smokers and dual users of cigarettes and e-cigarettes vary based on smoking status, but there is a common tendency to believe that nicotine is addictive, that addiction results from more than just nicotine, and that very low nicotine cigarettes will not necessarily reduce the addictiveness of cigarettes.

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Correlates of support for a nicotine-reduction policy in smokers with 6-week exposure to very low nicotine cigarettes.

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Correlates of support for a nicotine-reduction policy in smokers with 6-week exposure to very low nicotine cigarettes.

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