Abrupt nicotine reduction as an endgame policy: a randomised trial

Walker, Natalie; Fraser, Trish; Howe, Colin; Laugesen, Murray; Truman, Penelope; Parag, Varsha; Glover, Marewa; Bullen, Chris

doi:10.1136/tobaccocontrol-2014-051801

Cited by 21 publications

(24 citation statements)

References 25 publications

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“…Our analysis did not include three pilot randomized trials because of their short follow-up periods (less than 6 months) [ 35 , 36 , 37 ]. These trials used new-style tobacco products (smokeless tobacco and very low-nicotine content cigarettes) as a substitute for smoking for smokers who were not interested in quitting.…”

Section: Discussionmentioning

confidence: 99%

Effect of Smoking Reduction Therapy on Smoking Cessation for Smokers without an Intention to Quit: An Updated Systematic Review and Meta-Analysis of Randomized Controlled

Sun

et al. 2015

IJERPH

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Objective: Effective strategies are needed to encourage smoking cessation for smokers without an intention to quit. We systematically reviewed the literature to investigate whether smoking reduction therapy can increase the long-term cessation rates of smokers without an intention to quit. Methods: PubMed, Embase, and CENTRAL (Cochrane Central Register of Controlled Trials) were searched for randomized controlled trials (RCTs) on the effect of smoking reduction therapy on long-term smoking cessation in smokers without an intention to quit. The primary outcome was the cessation rate at the longest follow-up period. A random effects model was used to calculate pooled relative risks (RRs) and 95% confidence intervals (CIs). Results: Fourteen trials with a total of 7981 smokers were included. The pooled analysis suggested that reduction support plus medication significantly increased the long-term cessation of smokers without an intention to quit compared to reduction support plus placebo (RR, 1.97; 95% CI, 1.44–2.7; I2, 52%) or no intervention (RR, 1.93; 95% CI, 1.41–2.64; I2, 46%). In a subgroup of smokers who received varenicline or nicotine replacement therapy (NRT), the differences were also statistically significant. This suggests the safety of using NRT. The percentage of smokers with serious adverse events who discontinued because of these events in the non-NRT group was slightly significantly different than in the control group. Insufficient evidence is available to test the efficacy of reduction behavioural support in promoting long-term cessation among this population. Conclusions: The present meta-analysis indicated the efficacy of NRT- and varenicline-assisted reduction to achieve complete cessation among smokers without an intention to quit. Further evidence is needed to assess the efficacy and safety of reduction behavioural support and bupropion.

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Section: Discussionmentioning

confidence: 99%

Effect of Smoking Reduction Therapy on Smoking Cessation for Smokers without an Intention to Quit: An Updated Systematic Review and Meta-Analysis of Randomized Controlled

Sun

et al. 2015

IJERPH

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“…Compared to control cigarettes with 15.8 mg nicotine per gram of tobacco, use of cigarettes with only 0.4 mg/g nicotine by smokers who are not currently interested in quitting leads to decreased nicotine exposure,4–6 decreased cigarette dependence,5 7 fewer cigarettes smoked per day5 8 and increased likelihood of contemplating or making a quit attempt 5 7. Standardised effect sizes comparing 0.4–15.8 mg/g nicotine are moderate (Fagerström Test for Nicotine Dependence: 0.65) to large (cigarettes per day: 0.79; urinary total nicotine equivalents: 0.82) after 6 weeks of use5 (EC Donny, 2016, unpublished observations).…”

Section: Evidence-based Potential Benefits Of Reducing Nicotine In CImentioning

confidence: 99%

“…If available at the same price, VLNC cigarettes are unlikely to be widely used 7. If available at a significantly lower price, VLNC cigarettes could substitute for normal cigarettes.…”

Section: Common Questionsmentioning

confidence: 99%

Reducing the nicotine content of combusted tobacco products sold in New Zealand

et al. 2016

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Large reductions in nicotine content could dramatically reduce reinforcement from and dependence on cigarettes. In this article, we summarise the potential benefits of reducing nicotine in combusted tobacco and address some of the common concerns. We focus specifically on New Zealand because it may be ideally situated to implement such a policy. The available data suggest that, in current smokers, very low nicotine content (VLNC) cigarettes decrease nicotine exposure, decrease cigarette dependence, reduce the number of cigarettes smoked per day and increase the likelihood of contemplating, making and succeeding at a quit attempt. New smokers would almost certainly be exposed to far less nicotine as a result of smoking VLNC cigarettes and, consequently, would probably be less likely to become chronic, dependent, smokers. Many of the concerns about reducing nicotine including compensatory smoking, an exacerbation of psychiatric symptoms, the perception that VLNC cigarettes are less harmful, and the potential for a black market are either not supported by the available data, likely mitigated by other factors including the availability of nicotine-containing e-cigarettes, or unlikely to offset the potential benefit to public health. Although not all concerns have been addressed or can be a priori, the magnitude of the potential benefits and the growing evidence of relatively few potential harms should make nicotine reduction one of the centrepieces for discussion of how to rapidly advance tobacco control. Policies that aim to render the most toxic tobacco products less addictive could help New Zealand attain their goal of becoming smokefree by 2025.

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“…The US Food and Drug Administration and regulators in other countries have the authority to establish tobacco product standards [1]. Mandated reductions in the nicotine content of cigarettes to make them less addictive has been discussed in the United States [2][3][4] and New Zealand [5] and in international meetings [6] as a promising cigarette 'end-game' approach [7]. If this intervention is successful in one country, it is likely others will try similar approaches.…”

Section: Introductionmentioning

confidence: 99%

Estimations and predictors of non‐compliance in switchers to reduced nicotine content cigarettes

et al. 2016

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Background and Aims Clinical trials on the impact and safety of reduced nicotine content cigarettes (RNCs) are ongoing, and an important methodological concern is participant compliance with smoking only RNCs. Our aims were to measure non-compliance biochemically with urine cotinine (COT) and total nicotine equivalents (TNEs), compare with self-reported non-compliance, and identify associated covariates. Design Secondary analysis of a double-blind, parallel, randomized clinical trial. Setting 10 research centers from the USA, enrolling participants from June 2013 to July 2014. Participants Volunteer sample of 242 participants (55% Caucasian), average age of 41.2 years, smoking at least 5 cigarettes per day (CPD). Intervention Smoking very low nicotine cigarettes (VLNCs; 0.4mg nicotine/g tobacco) for 6-weeks. Measurements The primary outcome was biochemically verified non-compliance, measured as thresholds of COT/CPD and TNE/CPD ratios, considering changes in nicotine content from conventional levels to VLNCs, and as an absolute threshold of Week 6 TNEs. Self-reported non-compliance was measured via daily phone calls. Key predictors included age, sex, race, menthol preference, nicotine metabolite ratio, time to first cigarette, dependence, CPD, TNEs, tar level and cigarette evaluation. Findings Estimates of non-compliance with smoking the VLNC cigarettes exclusively include: the biochemical ratios (both 78%), the Week 6 TNE threshold (76%) and self-report (39%). Of the key covariates, age, dependence and cigarette evaluations of satisfaction were significant; for age, younger participants more likely to be non-compliant (p=0.01; OR=0.98, 95% CI: 0.96–0.99). Dependence was significantly associated with self-reported non-compliance (p=0.01; OR=1.28, 95% CI: 1.06–1.55). Cigarette evaluations of satisfaction were significantly associated with non-compliance (p=0.001; OR=0.71, 95% CI: 0.61–0.82). Conclusions Biochemical assessments detect many more cases of non-compliance than self-report, and non-compliance with smoking VLNCs is observed in the majority of participants. Despite non-compliance, smokers reduced their intake of nicotine by an average of 60%, supporting the utility of nicotine reduction.

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Abrupt nicotine reduction as an endgame policy: a randomised trial

Abstract: Smokers unmotivated to quit reduce their usual cigarette consumption (and thus nicotine exposure) when VLNC cigarettes are made available at a significantly reduced price.

Cited by 21 publications

References 25 publications

Effect of Smoking Reduction Therapy on Smoking Cessation for Smokers without an Intention to Quit: An Updated Systematic Review and Meta-Analysis of Randomized Controlled

Effect of Smoking Reduction Therapy on Smoking Cessation for Smokers without an Intention to Quit: An Updated Systematic Review and Meta-Analysis of Randomized Controlled

Reducing the nicotine content of combusted tobacco products sold in New Zealand

Estimations and predictors of non‐compliance in switchers to reduced nicotine content cigarettes

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