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Nicotine-Free E-Cigarettes Might Promote Tobacco Smoking Reduction Better Than Nicotine Delivery Devices: Results of a Double-Blind Randomized Controlled Trial at 1 Year.

ABSTRACT: The purpose of the present study was to determine whether the use of e-cigarettes to aid in quitting contributed to the increase in the pulmonary health of chronic smokers. The efficacy of e-cigarettes to support a successful smoking cessation attempt was also investigated. A total of 210 smokers (78 women) were enrolled in a screening program for the early detection of lung cancer and distributed in three arms: nicotine e-cigarette plus support, nicotine-free e-cigarette plus support, and support. Results showed that participants in the nicotine e-cigarette arm had a significant and fast decrease in daily cigarettes, but that later they resume smoking more than the other two groups. Conversely, participants in the other two arms showed similar daily consumption at the two evaluation points. Among abstinent participants, only 12.5% reported cough, while 48% of current smokers had pulmonary symptoms. Our study suggests that, in the long run, the use of a nicotine-free liquid may favor reducing smoking and could be considered a good option in a clinical setting.

SUBMITTER: Lucchiari C

PROVIDER: S-EPMC9717729 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Nicotine-Free E-Cigarettes Might Promote Tobacco Smoking Reduction Better Than Nicotine Delivery Devices: Results of a Double-Blind Randomized Controlled Trial at 1 Year.

Lucchiari Claudio C Masiero Marianna M Mazzocco Ketti K Veronesi Giulia G Maisonneuve Patrick P Jemos Costantino C Salè Emanuela Omodeo EO Spina Stefania S Bertolotti Raffaella R Busacchio Derna D Pravettoni Gabriella G

Current oncology (Toronto, Ont.) 20221111 11

The purpose of the present study was to determine whether the use of e-cigarettes to aid in quitting contributed to the increase in the pulmonary health of chronic smokers. The efficacy of e-cigarettes to support a successful smoking cessation attempt was also investigated. A total of 210 smokers (78 women) were enrolled in a screening program for the early detection of lung cancer and distributed in three arms: nicotine e-cigarette plus support, nicotine-free e-cigarette plus support, and suppo ...[more]

PMID: 36421329

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Project description:IntroductionElectronic cigarettes (EC) mainly with nicotine content are widely used worldwide. Although the number of publications about its use is increasing exponentially, evidence-based, unbiased, conclusive, head-to-head comparisons about its efficacy and safety as an aid for smoking cessation are lacking. METHODS AND ANALYSIS: Design: randomised, placebo and reference treatment-controlled, multicentre, double-blind, double-dummy, parallel-group trial. Participants: smokers smoking at least 10 cigarettes/day in the past year and motivated to quit, aged 18-70 years. Interventions: (A) EC without nicotine (ECwoN) plus placebo tablets of varenicline administered by oral route: placebo condition, (B) EC with nicotine (ECwN) plus placebo tablets of varenicline: ECwN condition. Voltage regulated EC will be used with liquid containing 12 mg/mL of nicotine for ad libitum use. Flavour: blond tobacco. (C) Reference: ECwoN plus 0.5 mg varenicline tablets: varenicline condition. Varenicline administered according to the marketing authorisationauthorisation. Treatment duration: 1 week+3 months. Primary outcome: continuous smoking abstinence rate (CAR) (abstinence from conventional/combustible cigarettes) during the last 4 weeks (weeks 9-12) of the treatment period defined as self-report of no smoking during the previous 2 weeks and expired air carbon monoxide ≤8 at visit 4 at week 10 after target quit date (TQD), that is, 11 weeks after treatment initiation AND at visit 5, week 12 after TQD, that is, 13 weeks after treatment initiation. Secondary outcomes: safety profile; point prevalence abstinence rate; CAR confirmed by urinary anabasine concentration; changes in cigarettes/day consumption; craving for tobacco and withdrawal symptoms with respect of baseline.Ethics and disseminationThe ethics committee approval was obtained on 17 April 2018. All data collected about the study participants will be anonymised. Investigators will communicate trial results to participants, health authorities, healthcare professionals, the public and other relevant groups without any publication restrictions.Trial registration numberNCT03630614; Pre-results.

Project description:BackgroundThe U.S. Food and Drug Administration and the government of New Zealand have proposed a reduction of the nicotine content in cigarettes to very low levels. This study examined the potential effects of this regulation in smokers with affective disorders.MethodsIn a randomized controlled parallel group trial conducted at two sites in the USA (Penn State University, Hershey, PA and Massachusetts General Hospital, Boston, MA) 188 adult smokers with a current (n = 118) or lifetime (n = 70) anxiety or unipolar mood disorder, not planning to quit in the next 6 months, were randomly assigned (1:1) to smoke either Usual Nicotine Content (UNC) (11.6 mg nicotine/cigarette) research cigarettes, or Reduced Nicotine Content (RNC) research cigarettes where the nicotine content per cigarette was progressively reduced to 0.2 mg in five steps over 18 weeks. Participants were then offered the choice to either receive assistance to quit smoking, receive free research cigarettes, or resume using their own cigarette brand during a 12-week follow-up period. Main outcomes were biomarkers of nicotine and toxicant exposure, smoking behavior and dependence and severity of psychiatric symptoms. The pre-registered primary outcome was plasma cotinine.ResultsA total of 143 (76.1%) randomized participants completed the randomized phase of the trial, 69 (73.4%) in the RNC group and 74 (78.8%) in the UNC group. After switching to the lowest nicotine content cigarettes, compared to smokers in the UNC group, at the last randomized visit the RNC group had significantly lower plasma cotinine (metabolite of nicotine): difference between groups, -175.7, 95% CI [-218.3, -133.1] ng/ml. Urine NNAL (metabolite of NNK, a lung carcinogen), exhaled carbon-monoxide, cigarette consumption, and cigarette dependence were also significantly lower in the RNC group than the UNC group. No between-group differences were found on a range of other biomarkers (e.g. 8-isoprostanes) or health indicators (e.g. blood pressure), or on 5 different psychiatric questionnaires, including the Kessler K6 measure of psychological distress. At the end of the subsequent 12-week treatment choice phase, those randomized to the RNC group were more likely to have quit smoking, based on initial intent-to-treat sample, n = 188 (18.1% RNC v 4.3% UNC, p = 0.004).ConclusionReducing nicotine content in cigarettes to very low levels reduces some toxicant exposures and cigarette addiction and increases smoking cessation in smokers with mood and/or anxiety disorders, without worsening mental health.Trial registrationTRN: NCT01928758, registered August 21, 2013.

Project description:BackgroundThe success of pharmacotherapies for smoking cessation in real-life remains limited, with a significant number of long-term relapses. Despite first promising results, the duration of the effectiveness of electronic cigarettes is still unknown. Our objective was to assess the duration of the effectiveness of electronic cigarettes on smoking cessation and reduction in daily smokers.MethodsThe databases EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov and PUBMED were consulted until March 23, 2022. We selected only randomized controlled trials with daily adult smokers. The intervention was the nicotinic electronic cigarette vs. non-nicotine electronic cigarette or other validated pharmacotherapies (varenicline, bupropion and nicotine replacement therapy). The minimum duration of the intervention was 3 months, with a follow-up of at least 6 months. Two independent reviewers used the PRISMA guidelines. The primary endpoint was smoking cessation at the end of the intervention and follow-up periods confirmed by a reduction in expired CO < 10 ppm. The reduction was defined as at least 50% of the initial consumption or by a decrease of daily mean cigarette consumption at the end of the intervention and follow-up periods.ResultsAbstinence at the end of the intervention and follow-up periods was significantly higher in the nicotine electronic cigarette group, compared to nicotine replacement therapy (NRT) [respectively: RR: 1.37 (CI 95%: 1.32-2.93) and RR: 1.49 (CI 95%: 1.14-1.95)] and to the non-nicotine electronic cigarette condition [respectively: RR: 1.97 (CI 95%: 1.18-2.68) and RR: 1.66 (CI 95%: 1.01-2.73)]. With regard to smoking reduction, the electronic cigarette with nicotine is significantly more effective than NRT at the end of the intervention and follow-up periods [respectively RR: 1.48 (CI 95%: 1.04-2.10) and RR: 1.47 (CI 95%: 1.18-1.82)] and non-nicotine electronic cigarette in the long term [RR: 1.31 (CI 95%: 1.02-1.68)].ConclusionsThis meta-analysis shows the duration of the effectiveness of the nicotine electronic cigarette vs. non-nicotine electronic cigarette and NRT on smoking cessation and reduction. There are still uncertainties about the risks of its long-term use and its potential role as a gateway into smoking, particularly among young people.

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.

Dataset Information

Nicotine-Free E-Cigarettes Might Promote Tobacco Smoking Reduction Better Than Nicotine Delivery Devices: Results of a Double-Blind Randomized Controlled Trial at 1 Year.

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Nicotine-Free E-Cigarettes Might Promote Tobacco Smoking Reduction Better Than Nicotine Delivery Devices: Results of a Double-Blind Randomized Controlled Trial at 1 Year.

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