The study found that the antismoking medication varenicline can increase rates of smoking abstinence without causing serious adverse events.

A groundbreaking study conducted by COEHAR researchers has unveiled the effectiveness and safety of varenicline in aiding dual users individuals who concurrently smoke cigarettes and use e-cigarettes in their quest to quit smoking. 

The study – published in eClinicalMedicine, part of The Lancet Discovery Sciencefound that the antismoking medication varenicline can increase rates of smoking abstinence without causing serious adverse events.


Catania, 22 November 2023 – The growing interest among dual users to quit smoking has surged, particularly amid the COVID-19 pandemic. Motivated by concerns about health risks, the high expenses of traditional tobacco products, and the desire for freedom from tobacco dependency, dual users seek ways to break their smoking habit. However, there’s been a notable lack of information tailored to this specific group seeking cessation strategies.

COEHAR researchers, led by Prof. Pasquale Caponnetto from the Department of Educational Science at the University of Catania, conducted this pioneering double-blind, single-center, randomized controlled trial involving 155 individuals who both vaped (mainly using refillable vaping products) and smoked, all aiming to quit smoking.

The study revealed that varenicline significantly aided dual users in quitting smoking, resulting in sustained abstinence from tobacco cigarette use. Similar to what is observed in cigarette smokers high level of depressive symptoms and be male reduced the odds of success for abstinence from tobacco cigarettes also in individuals who smoke and use e-cigarettes. The presence of depressive symptoms and factors related to gender are known to be among the strongest predictors of poor success in quitting smoking among adult cigarette smokers. While there were differences in adverse events between treatment groups, varenicline was generally well tolerated among individuals who both vape and smoke.

Almost half of individuals who simultaneously smoke and use e-cigarettes continue this habit for a year, with 44% eventually returning exclusively to smoking” Prof. Pasquale Caponnetto highlighted. “Our study data indicates that varenicline, coupled with counseling, may facilitate prolonged abstinence without significant adverse events an additional option for those seeking cessation.”

Of the 155 participants, 114 completed all treatment phase visits (initial 12 weeks). Within this group, 50.0% in the varenicline group achieved continuous complete abstinence from combustible cigarettes by week 12. Moreover, reduction in smoking consumption was observed in 25.4% and 18.2% of participants at weeks 12 and 24, respectively. Remarkably, the observed efficacy in the varenicline group of established dual users exceeded that reported in similar randomized controlled trials (RCTs) of varenicline for smoking cessation in the general population. Contrary to anticipated outcomes based on earlier RCTs of varenicline for smoking cessation in the general population, the efficacy observed within the varenicline group of established dual users surpassed those previously reported.

Prof. Jasjit S. Ahluwalia from Brown University School of Public Health and Alpert School of Medicine (Providence, RI, USA) added: “Remarkably, the level of efficacy in the varenicline group of established dual users exceeded those reported in randomized controlled trials (RCTs) for smoking cessation in smokers in the general population. This divergence is thought to stem from heightened participant motivation levels and a documented compensatory/substitution phenomenon attributed to increased EC usage within the varenicline arm”.

Additionally, a small number of cigarette quitters also ceased using e-cigarettes by the end of the study. In a similar study published a few months earlier in July, CoEHAR researchers also evaluated the efficacy and tolerability of varenicline in aiding people who exclusively use e-cigarettes to cease vaping. The results from that randomized controlled trial showcased the drug’s effectiveness when combined with specific vaping cessation counseling program, proving to be a successful method for quitting e-cigarettes.

Prof. Riccardo Polosa, the founder of CoEHAR, emphasized, “This study marks the world’s first scientific exploration into a combined approach involving e-cigarettes, smoking cessation medications, and cognitive-behavioral therapy to achieve cessation goals. It demonstrates the potential to expand tobacco harm reduction to align with existing cessation guidelines, particularly for specific groups like dual users an area previously unexplored. The integration of vaping into cessation guidelines is essential.”

Pasquale Caponnetto interview


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