The use of the drug combined with an innovative vaping cessation counseling program was safe and effective for quitting e-cigarettes. The combined approach also decreased the chances of relapsing back to vaping and smoking.


CoEHAR researchers have evaluated the efficacy and tolerability of varenicline, a drug used in smoking cessation programs, to help people who use e-cigarettes to stop vaping. The use of the drug combined with an innovative vaping cessation counseling program was safe and effective for quitting e-cigarettes. The combined approach also decreased the chances of relapsing back to vaping and smoking. These positive findings establish a benchmark of intervention effectiveness and may support the use of varenicline combined with counseling in vaping cessation programs.

LINK of the study

Catania, July 5th – The popularity of nicotine-releasing devices, such as electronic cigarettes, is constantly increasing. Among cigarette smokers, E-cigarette users report buying them mainly to help abstain from smoking cigarettes, relieve cigarette withdrawal symptoms, save money, and have a “smoking” experience with reduced health risks. However, perceptions of e-cigarette being equally or even more harmful than combustible cigarettes have increased among many users, and there is growing interest in quitting vaping. 

It is unclear whether existing smoking cessation guidelines can be applied to vaping products and there are no studies of the efficacy of medications approved for smoking cessation for aiding vaping cessation. Varenicline, a drug that alleviates nicotine withdrawal symptoms and cravings, is the most effective smoking cessation medication. However, the efficacy and safety of varenicline for vaping cessation have not been studied.

To address this, CoEHAR researchers conducted the first randomized controlled trial of varenicline in 140 exclusive vapers and examined abstinence rates from e-cigarettes. The results of this trial have been published today in the prestigious Journal, BMC Medicine.

The study “Varenicline and counseling for vaping cessation: A double-blind, randomized, parallel-group, placebo-controlled trial“, shows for the first time that inclusion of varenicline in a vaping cessation program for people who use e-cigarettes and intending to quit may result in abstinence. E-cigarette abstinence rate in the varenicline group was 34.3%, significantly higher than the abstinence rate of 17.2% in the placebo group. Moreover, varenicline has shown to have an acceptable safety profile.

In our study sample, varenicline doubled the chances of quitting vaping ” explains Pasquale Caponetto, professor of Clinical Psychology at the University of Catania and first author of the study “this is quite remarkable considering that the drug only alleviates nicotine withdrawal symptoms and cravings, but cannot replace the need for vaping-related rituals”.

 “We are proud to share the results of the first RCT of varenicline for vaping cessation. Vaping is a harm-reduction approach to smoking and can lead to smoking cessation. Here we set the principle that for those seeking complete nicotine cessation Varenicline combined with professional support can help them do so. Needless to say, the best health outcome is achieved when people don’t vape or smoke”, commented prof. Riccardo Polosa, CoEHAR founder.


Particular attention was given to the research and selection of participants. We included exclusive adult e-cigarette users who were vaping daily, expressed the intention to quit, and had made at least one serious quit vaping attempt.

Subjects were randomly assigned to either varenicline or placebo group. All participants in both treatment groups received vaping cessation counseling from experts in vaping and nicotine addiction to maximize the effectiveness of drug treatment. Prolonged abstinence was verified by measuring the cotinine level in participants’ saliva.

Upon analyzing the entire group of subjects completing the study, we observed a reduction in vaping consumption of 33.6% and 26.3% at weeks 12 and 24, respectively. Notably, no subject in the study relapsed to tobacco cigarette smoking.

“I believe that the success of our strategy was to provide highly motivated participants with a combined approach for vaping cessation, a structured vaping reduction plan together with the use of a drug controlling for nicotine dependence” explains prof. Polosa.

The presence of cohabitant vapers and a high level of anxiety significantly decreased the chances of successfully abstaining from vaping.

This study suggests that incorporating of Varenicline in a vaping cessation program for adult e-cigarette users may lead to prolonged abstinence without serious adverse effects. Such findings could guide health authorities in assisting consumers who desire complete nicotine cessation. However, it is essential to conduct longer follow-up studies to verify the long-term efficacy.


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