Background People who smoke and who face challenges trying to quit or wish to continue to smoke may benefit by switching from traditional cigarettes to noncombustible nicotine delivery alternatives, such as heated tobacco products (HTPs) and electronic cigarettes (ECs). HTPs and ECs are being increasingly used to quit smoking, but there are limited data about their effectiveness. Objective We conducted the first randomized controlled trial comparing quit rates between HTPs and ECs among people who smoke and do not intend to quit. Methods We conducted a 12-week randomized noninferiority switching trial to compare effectiveness, tolerability, and product satisfaction between HTPs (IQOS 2.4 Plus) and refillable ECs (JustFog Q16) among people who do not intend to quit. The cessation intervention included motivational counseling. The primary endpoint of the study was the carbon monoxide–confirmed continuous abstinence rate from week 4 to week 12 (CAR weeks 4-12). The secondary endpoints included the continuous self-reported ≥50% reduction in cigarette consumption rate (continuous reduction rate) from week 4 to week 12 (CRR weeks 4-12) and 7-day point prevalence of smoking abstinence. Results A total of 211 participants completed the study. High quit rates (CAR weeks 4-12) of 39.1% (43/110) and 30.8% (33/107) were observed for IQOS-HTP and JustFog-EC, respectively. The between-group difference for the CAR weeks 4-12 was not significant (P=.20). The CRR weeks 4-12 values for IQOS-HTP and JustFog-EC were 46.4% (51/110) and 39.3% (42/107), respectively, and the between-group difference was not significant (P=.24). At week 12, the 7-day point prevalence of smoking abstinence values for IQOS-HTP and JustFog-EC were 54.5% (60/110) and 41.1% (44/107), respectively. The most frequent adverse events were cough and reduced physical fitness. Both study products elicited a moderately pleasant user experience, and the between-group difference was not significant. A clinically relevant improvement in exercise tolerance was observed after switching to the combustion-free products under investigation. Risk perception for conventional cigarettes was consistently higher than that for the combustion-free study products under investigation. Conclusions Switching to HTPs elicited a marked reduction in cigarette consumption among people who smoke and do not intend to quit, which was comparable to refillable ECs. User experience and risk perception were similar between the HTPs and ECs under investigation. HTPs may be a useful addition to the arsenal of reduced-risk alternatives for tobacco cigarettes and may contribute to smoking cessation. However, longer follow-up studies are required to confirm significant and prolonged abstinence from smoking and to determine whether our results can be generalized outside smoking cessation services offering high levels of support. Trial Registration ClinicalTrials.gov NCT03569748; https://clinicaltrials.gov/ct2/show/NCT03569748

Vaping cessation is virtually unexplored. The efficacy and safety of varenicline for vaping cessation has not been studied and rigorous research is required to advance best practice and outcomes for people who use electronic cigarettes (EC) and want to quit. The objective is to evaluate the efficacy and safety of varenicline (1 mg BID, administered for 12 weeks, with follow-up to week 24) combined with vaping cessation counseling in exclusive daily EC users intending to quit vaping. Design: Double-blind, randomized, parallel-group, placebo-controlled trial. Setting: The study took place at a University-run smoking cessation center. Participants: People who exclusively use ECs daily and intend to quit vaping. Intervention: A total of 140 subjects were randomized to either varenicline (1 mg, administered twice daily for 12 weeks) plus counseling or placebo treatment (administered twice daily, for 12 weeks) plus counseling. The trial consisted of a 12-week treatment phase followed by a 12-week follow-up, nontreatment phase. Main outcomes and measures: The primary efficacy endpoint of the study was biochemically validated continuous abstinence rate (CAR) at weeks 4 to 12. Secondary efficacy end points were CAR at weeks 4 to 24 and 7-day point prevalence of vaping abstinence at weeks 12 and 24. CAR was significantly higher for varenicline vs placebo at each interval: weeks 4–12, 40.0

ABSTRACT Background Vaping cessation is virtually unexplored. The efficacy and safety of varenicline for vaping cessation has not been studied and rigorous research is required to advance best practice and outcomes for e-cigarettes users who want to quit. Methods Eligible patients were randomized to either varenicline (1 mg, administered twice daily for 12 weeks) or placebo treatment (administered twice daily, for 12 weeks) combined with vaping cessation counseling. The trial consisted of a 12-week treatment phase followed by a 12-week follow-up, nontreatment phase. The primary efficacy endpoint of the study was biochemically validated continuous abstinence rate (CAR) at weeks 4 to 12. Secondary efficacy end points were the CAR at weeks 4 to 24 and 7-day point prevalence of vaping abstinence at weeks 12 and 24. Results CAR was significantly higher for varenicline vs placebo at each interval: weeks 4-12, 40.0% and 20.0%, respectively (OR = 2.67, 95% CI = [1.25 - 5.68], P = 0.011); weeks 4-24, 34.3% for varenicline and 17.2% for placebo (OR = 2.52, 95% CI = [1.14 - 5.58], P = 0.0224). The 7-day point prevalence of vaping abstinence was also higher for the varenicline than placebo at each time point. Serious adverse events were infrequent in both groups and not treatment-related. Conclusions Inclusion of varenicline and counseling in a vaping cessation program for EC users intending to quit may result in prolonged abstinence. These positive findings may also help guiding future recommendations for vaping cessation by health authorities and healthcare providers.

Biorąc pod uwage, ze wielu pacjentow z przewleklą obturacyjną chorobą pluc (POChP) pali papierosy pomimo objawow, wazne jest zrozumienie dlugofalowego wplywu zdrowotnego zastepowania tradycyjnych papierosow poprzez podgrzewane produkty tytoniowe (HTP, heated tobacco products). Przez 3 lata monitorowano parametry zdrowotne pacjentow z POChP, ktorzy znacznie ograniczyli palenie lub zaprzestali palenia papierosow po przejściu na HTP. Zmiany w liczbie codziennie wypalanych papierosow, rocznej czestości zaostrzen choroby, wskaźnikach czynności pluc, wyniku kwestionariusza ciezkości POChP wedlug oceny wlasnej pacjentow (wskaźnik CAT) i wyniku testu 6-minutowego marszu (6MWD) w stosunku do wartości wyjściowych byly mierzone u pacjentow z POChP stosujących HTP w 12., 24. i 36. miesiącu. Porownano je z grupą pacjentow z POChP dopasowanych pod wzgledem wieku i plci, ktorzy nadal palili papierosy. Kompletne zestawy danych byly dostepne u 38 pacjentow (po 19 w kazdej grupie). U osob stosujących HTP odnotowano znaczne zmniejszenie średniej (± SD) rocznej czestości zaostrzen POChP z 2,1 (± 0,9) na początku badania do 1,4 (± 0,8), 1,2 (± 0,8) i 1,3 (± 0,8) po 12, 24 i 36 miesiącach obserwacji (p < 0,05 dla wszystkich wizyt). Ponadto we wszystkich trzech punktach czasowych w kohorcie HTP stwierdzono znaczną i klinicznie istotną poprawe wynikow CAT i 6MWD. Nie zaobserwowano istotnych zmian u pacjentow z POChP, ktorzy kontynuowali palenie. Niniejsze badanie jestpierwszym, w ktore opisano dlugoterminowe skutki zdrowotne stosowania HTP u pacjentow z POChP. Poprawe objawow ze strony ukladu oddechowego, tolerancji wysilku, jakości zycia i czestości zaostrzen choroby zaobserwowano konsekwentnie u pacjentow z POChP, ktorzy powstrzymali sie od palenia lub znacznie ograniczyli palenie papierosow poprzez przestawienie sie na stosowanie HTP. Slowa kluczowe: zaprzestanie palenia, podgrzewane produkty tytoniowe, IQOS, glo, POChP, zmniejszenie szkod związanych z paleniem tytoniu

Given that many patients with chronic obstructive pulmonary disease (COPD) smoke despite their symptoms, it is important to understand the long-term health impact of cigarette substitution with heated tobacco products (HTPs). We monitored health parameters for 3 years in COPD patients who substantially attenuated or ceased cigarette consumption after switching to HTPs. Changes in daily cigarette smoking, annualized disease exacerbations, lung function indices, patient-reported outcomes (CAT scores) and 6-minute walk distance (6MWD) from baseline were measured in COPD patients using HTPs at 12, 24 and 36 months. These were compared to a group of age- and sex-matched COPD patients who continued smoking. Complete data sets were available for 38 patients (19 in each group). Subjects using HTPs had a substantial decrease in annualized COPD exacerbations within the group mean (± SD) from 2.1 (± 0.9) at baseline to 1.4 (± 0.8), 1.2 (± 0.8) and 1.3 (± 0.8) at 12-, 24- and 36-month follow-up (p < 0.05 for all visits). In addition, substantial and clinically significant improvements in CAT scores and 6MWD were identified at all three time points in the HTP cohort. No significant changes were observed in COPD patients who continued smoking. This study is the first to describe the long-term health effects of HTP use in COPD patients. Consistent improvements in respiratory symptoms, exercise tolerance, quality of life, and rate of disease exacerbations were observed in patients with COPD who abstained from smoking or substantially reduced their cigarette consumption by switching to HTP use.

Background and Aims: The long-term health effects of the use of electronic cigarettes (ECs) in patients with chronic obstructive pulmonary disease (COPD) are largely unexplored. We present findings from a 5-year prospective assessment of respiratory parameters in a cohort of COPD patients who substantially reduced conventional smoking or achieved abstinence by switching to ECs. Methods: Patients were evaluated prospectively for their measurements of respiratory exacerbations, spirometric indices, quality of life using the COPD assessment tool (CAT), 6-min walk distance (6MWD), as well as conventional cigarette consumption. Baseline measurements prior to switching to EC use were compared with follow-up visits at 12-, 24-, 48- and 60-months. Age- and sex-matched COPD patients reporting to be regular smokers (not using ECs) were the reference group for the analysis. Results: Complete data were available from 39 patients. Those in the EC user group achieved a marked decline in cigarette smoking or abstinence. COPD EC users had a significant diminution in COPD exacerbations; with the mean (±SD) exacerbation rate falling from 2.3 (±0.9) at baseline to 1.1 (±1.0) at 5 years ( p < 0.001), whereas no significant changes were observed in the control group. Significant and constant improvements in lung function, CAT scores and 6MWD were reported in the EC user group over the 5-year observation period compared with the reference group ( p < 0.05). Conclusion: The present study suggests that EC use may ameliorate objective and subjective COPD outcomes, and that the benefits gained appear to persist long term. EC use for abstinence and smoking reduction may ameliorate some of the harm resulting from tobacco smoking in COPD patients.

BackgroundDespite the introduction of tobacco control measures, smoking remains highly prevalent in most EU countries. In Italy, one in four adults were still regular smokers in 2017. Increasing use of combustion-free delivering nicotine technologies for cigarette substitution may accelerate the current downward trends in smoking prevalence. Whether Heated Tobacco Products (HTPs) are more effective tobacco smoking substitutes that may potentially facilitate adoption and full conversion compared to e-cigarettes (ECs) is not known.We have designed a prospective study to compare changes in cigarette consumption and adoption rates among smokers randomized to either HTPs or ECs. Product acceptability, tolerability, and their tobacco harm reduction potential will be also compared.Methods220 healthy smokers, not motivated to quit, will be randomized into a 12-weeks single-center, open label, non-inferiority trial comparing study outcomes from HTPs vs. ECs use. The primary outcome will be biochemically verified self-reported continuous abstinence at 12-weeks from the previous visit. Secondary outcomes will include: smoking reduction from baseline, adoption rates and product acceptability, tolerability, changes in step test values and in the level of selected biomarkers of exposure in exhaled breath (i.e. eCO) and in spot urine samples. A follow-up visit will be also included at 24-weeks to review product usage and smoking behavior under naturalistic condition of use.Recruitment of participants started in May 2019 and enrolment is expected to be completed in November 2019.DiscussionThis will be the first study directly comparing Heated Tobacco Products with Electronic Cigarettes in term of reduction in cigarette consumption, adoption rates, product acceptability, tolerability, and tobacco harm reduction potential. This knowledge can contribute to a better understanding of the potential role of this new technology in the evolving nicotine consumer market.Trial registrationClinicalTrials.gov ID: NCT03569748.Registered June 25, 2018.https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=1&cx=-jg9qo4.

Heated tobacco products (HTPs) are new tech devices that release nicotine and other volatile compounds into an inhalable aerosol by heating the tobacco. At their operating temperatures, tobacco combustion is unlikely. The aim of this randomized cross-over study was to measure the exposure levels of the combustion marker, carbon monoxide in the exhaled breath (eCO) of subjects after use of two HTPs and to compare these levels with participants’ own brand of cigarettes. A total of 12 healthy smokers who reported smoking ≥10 conventional cigarettes per day for at least 5 years took part in the study. Product administration consisted of a first round of 10 puffs, which was followed by an identical second round after a 5 min pause in between rounds. After obtaining a baseline eCO value, this measure was recorded at 5, 10, 15, 30, and 45 min after the first puff of the first round. In contrast to combustible cigarettes, no eCO elevations were observed in the exhaled breath after use of the HTPs under investigation in any of the study participants.