Dataset Information

Effectiveness of switching to very low nicotine content cigarettes plus nicotine patch versus reducing daily cigarette consumption plus nicotine patch to decrease dependence: an exploratory randomized trial.

ABSTRACT:

Background and aims

The United States Food and Drug Administration has proposed regulation to require that cigarettes contain very low nicotine content (VLNC). In contrast, reducing the number of cigarettes per day (CPD) is the most common current method to reduce nicotine. This trial aims to explore whether gradually transitioning to VLNC cigarettes plus nicotine patch or reducing CPD plus nicotine patch is more effective at decreasing nicotine dependence.

Design

A two-arm, individually randomized open-label trial.

Setting

Community setting, Vermont, USA.

Participants

Sixty-eight adult daily smokers (40% female) of ≥ 10 cigarettes/day who were not planning to quit in the next 30 days.

Interventions

All participants smoked study cigarettes with a nicotine yield similar to most commercial cigarettes ad libitum for 1 week (baseline). Participants then gradually reduced to 70, 35, 15 and 3% of baseline nicotine over 4 weeks by either (a) transitioning to lower nicotine content cigarettes (n = 36) or (b) reducing the number of full nicotine cigarettes (n = 32). All participants received nicotine patches.

Measurements

The primary outcome was change in nicotine dependence assessed at baseline and weekly during the intervention with the Nicotine Dependence Syndrome Scale.

Findings

Dependence declined over time for both VLNC and CPD participants, but declined more for VLNC (mean decrease in Z-score of 1.0) than CPD (mean decrease in Z-score of 0.5) participants over time (interaction P = 0.018).

Conclusions

Transitioning to very low nicotine content cigarettes reduced nicotine dependence over a 4-week period to a greater extent than reducing cigarettes per day when both conditions were aided by nicotine patch.

SUBMITTER: Klemperer EM

PROVIDER: S-EPMC6682423 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of switching to very low nicotine content cigarettes plus nicotine patch versus reducing daily cigarette consumption plus nicotine patch to decrease dependence: an exploratory randomized trial.

Klemperer Elias M EM Hughes John R JR Callas Peter W PW Benner Joy A JA Morley Nicholas E NE

Addiction (Abingdon, England) 20190630 9

<h4>Background and aims</h4>The United States Food and Drug Administration has proposed regulation to require that cigarettes contain very low nicotine content (VLNC). In contrast, reducing the number of cigarettes per day (CPD) is the most common current method to reduce nicotine. This trial aims to explore whether gradually transitioning to VLNC cigarettes plus nicotine patch or reducing CPD plus nicotine patch is more effective at decreasing nicotine dependence.<h4>Design</h4>A two-arm, indiv ...[more]

PMID: 31106492

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Project description:IntroductionThe U.S. Food and Drug Administration (FDA) has proposed lowering the nicotine content of cigarettes to a minimally addictive level to increase smoking cessation and reduce initiation. This study has two aims: (1) to determine when cigarette manufacturers had the technical capability to reduce cigarette nicotine content and (2) to estimate the lost public health benefits of implementing a standard in 1965, 1975, or 1985.MethodsTo determine the technical capability of cigarette companies, we reviewed public patents and internal cigarette company business records using the Truth Tobacco Industry Documents. To evaluate the impact of a very low nicotine content cigarette (VLNC) standard on smoking attributable deaths (SADs) and life-years lost (LYLs), we applied a validated (CISNET) model that uses past smoking data, along with estimates of the potential impact of VLNCs derived from expert elicitation.ResultsCigarette manufacturers recognized that cigarettes were deadly and addictive before 1964. Manufacturers have had the technical capability to lower cigarette nicotine content for decades. Our model projected that a standard implemented in 1965 could have averted 21 million SADs (54% reduction) and 272 million LYLs (64% reduction) from 1965 to 2064, a standard implemented in 1975 could have averted 18.9 million SADs and 245.4 million LYLs from 1975 to 2074, and a standard implemented in 1985 could have averted 16.3 million SADs and 211.5 million LYLs from 1985 to 2084.ConclusionsMillions of premature deaths could have been averted if companies had only sold VLNCs decades ago. FDA should act immediately to implement a VLNC standard.ImplicationsPrior research has shown that a mandated reduction in the nicotine content of cigarettes could reduce the prevalence of smoking and improve public health. Here we report that cigarette manufacturers have had the ability to voluntarily implement such a standard for decades. We use a well-validated model to demonstrate that millions of smoking attributable deaths and life-years lost would have been averted if the industry had implemented such a standard.

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:IntroductionHow nicotine dependence will be affected when current smokers initiate electronic cigarette (e-cigarette) use to reduce cigarette smoking is unknown. This study evaluated cigarette, e-cigarette, and total nicotine dependence more than 6 months among smokers reducing cigarette consumption by replacing with e-cigarettes.Aims and methodsAdult cigarette smokers were randomized to one of four conditions (36 mg/ml e-cigarette, 8 mg/ml e-cigarette, 0 mg/ml e-cigarette, or cigarette-substitute [CS] [provided at no cost]) and instructed to reduce their cigarette smoking by 75% at 1 month. Participants completed follow-up at 1, 3, and 6 months. The Penn State Nicotine Dependence Index (PSNDI) measured dependence on cigarettes (PSCDI) and e-cigarettes (PSECDI). Urine cotinine measured total nicotine exposure. Linear mixed effects models for each outcome were conducted and included interaction terms between visit and condition.ResultsParticipants (n = 520) were 58.8% female, 67.3% White, and 48.0 years old. At baseline, the median number of cigarettes smoked per day was 17.3 and the mean PSCDI score was 13.4, with no significant differences between conditions. Participants in the e-cigarette conditions reported significantly lower PSCDI scores, compared with baseline, and with the CS condition at all follow-up visits. Those in the 36 mg/ml e-cigarette condition reported greater PSECDI scores at 6 months, compared with baseline and the 0 mg/ml and 8 mg/ml conditions. At all follow-up visits, there were no differences in total nicotine exposure compared to baseline, nor between any conditions.ConclusionsE-cigarette use was associated with reduced cigarette dependence, compared to the CS, without significant increases in total nicotine exposure.ImplicationsInitiation of electronic cigarette use while continuing to smoke could potentially increase nicotine dependence. In this randomized trial aimed at helping smokers to reduce their cigarette intake, we found that use of an e-cigarette was associated with a reduction in cigarette dependence and an increase in e-cigarette dependence (in the condition with the highest nicotine concentration only), with no long term increase in total nicotine dependence or nicotine exposure.

Dataset Information

Effectiveness of switching to very low nicotine content cigarettes plus nicotine patch versus reducing daily cigarette consumption plus nicotine patch to decrease dependence: an exploratory randomized trial.

Background and aims

Design

Setting

Participants

Interventions

Measurements

Findings

Conclusions

Publications

Effectiveness of switching to very low nicotine content cigarettes plus nicotine patch versus reducing daily cigarette consumption plus nicotine patch to decrease dependence: an exploratory randomized trial.

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