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Study on Using Nicotine Electronic Cigarettes and Varenicline for Smoking Cessation in Smokers of 10+ Cigarettes Daily

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on helping people who smoke at least 10 cigarettes a day to quit smoking. The study is comparing three different methods to assist with smoking cessation: electronic cigarettes with nicotine, electronic cigarettes without nicotine, and a medication called . Varenicline is a treatment that comes in the form of film-coated tablets and is known by the brand name . It is a licensed medication used to help people stop smoking.

The purpose of the study is to evaluate how effective electronic cigarettes containing nicotine are compared to electronic cigarettes without nicotine and to . Participants in the study will be randomly assigned to one of these three groups. The study will last for a period of three months, during which participants will be monitored to see if they can stop smoking continuously for the last four weeks of the treatment period. The study will also look at the safety of these methods by comparing any serious or non-serious side effects that may occur.

Throughout the study, researchers will also assess other factors such as the time it takes for participants to relapse into smoking after their target quit day, changes in the number of cigarettes smoked per day, cravings for tobacco, and withdrawal symptoms. The goal is to find out which method is most effective and safe for helping people quit smoking.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants are randomly assigned to one of three groups: electronic cigarettes with nicotine, electronic cigarettes without nicotine, or varenicline.

    The study is designed to be double-blind, meaning neither the participants nor the researchers know which group each participant is in.

  2. Step 2

    Medication administration

    Participants in the varenicline group receive CHAMPIX 0.5 mg film-coated tablets for oral use. The dosage and frequency are determined by the study protocol.

    Participants in the electronic cigarette groups use either nicotine-containing or nicotine-free electronic cigarettes as per their group assignment.

  3. Step 3

    Treatment period

    The treatment period lasts for 3 months. During this time, participants are expected to follow the assigned treatment regimen.

    Participants are monitored for smoking abstinence, which is defined as not smoking during the last 4 weeks of the treatment period.

  4. Step 4

    Monitoring and assessments

    Throughout the study, participants attend regular visits for monitoring and assessments.

    Assessments include self-reported smoking abstinence, measurement of expired air carbon monoxide levels, and evaluation of any adverse events.

    Additional assessments focus on changes in cigarette consumption, cravings, and withdrawal symptoms.

  5. Step 5

    End of treatment evaluation

    At the end of the 3-month treatment period, participants undergo a final evaluation to assess their smoking status and any changes in health or behavior.

    The primary goal is to determine the continuous smoking abstinence rate and compare the effectiveness of the different treatments.

Who can join the trial?

3 criteria

  • Must be a smoker who has been smoking at least 10 cigarettes per day, whether factory-made or roll-your-own, in the past year.
  • Must be between the ages of 18 and 70 years old.
  • Must be motivated to quit smoking, which means scoring more than 5 on a visual rating scale from 0 (not motivated at all) to 10 (extremely motivated).

Who cannot join the trial?

1 criterion

  • People who have smoked at least 10 cigarettes a day in the past year cannot participate.
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Investigated drugs

  • Electronic Cigarettes with Nicotine (ECwN)

    are used in this trial to help people stop smoking. These e-cigarettes contain nicotine, which is the addictive substance found in traditional cigarettes. The goal is to see if using these e-cigarettes can help people quit smoking by providing a similar experience to smoking a regular cigarette but with less harmful effects.

  • Electronic Cigarettes without Nicotine (ECwoN)

    are also part of the trial. These e-cigarettes do not contain nicotine, so they do not have the addictive component of regular cigarettes. The purpose of including these is to determine if the act of using an e-cigarette, without the nicotine, can still help people quit smoking by mimicking the physical habit of smoking.

  • Varenicline

    is a medication used to help people stop smoking. It works by reducing cravings and withdrawal symptoms associated with quitting smoking. Varenicline also blocks the effects of nicotine from cigarettes, which can help reduce the pleasure derived from smoking. This medication is included in the trial as a reference to compare its effectiveness against the electronic cigarettes.

What is already known about the treatment

  • Varenicline

    Varenicline is taken orally in the form of tablets. It is currently a well-established medication in the medical literature, primarily used to help people quit smoking. The main therapeutic indication for varenicline is smoking cessation. It works by binding to nicotine receptors in the brain, reducing cravings and withdrawal symptoms while also blocking the pleasurable effects of nicotine. Varenicline is classified as a partial agonist at the nicotinic acetylcholine receptors.

  • Electronic Cigarettes with Nicotine (ECwN)

    These are inhaled through the mouth using a device that vaporizes a liquid containing nicotine. They are being studied as a potential aid for smoking cessation, with ongoing research evaluating their effectiveness compared to other methods. The main therapeutic indication is to help smokers reduce or quit smoking. The mechanism involves delivering nicotine to the brain, which can help reduce withdrawal symptoms and cravings. They are classified as nicotine replacement products.

  • Electronic Cigarettes without Nicotine (ECwoN)

    These are used similarly to their nicotine-containing counterparts, inhaled through a device that vaporizes a nicotine-free liquid. They are being investigated for their role in smoking cessation, particularly as a control in studies comparing them to nicotine-containing options. The main therapeutic indication is to assist in smoking cessation by providing a behavioral substitute for smoking without nicotine. They do not have a direct pharmacological action since they do not contain active substances like nicotine.

Investigated diseases

Nicotine Dependence – Nicotine dependence is a condition characterized by an addiction to nicotine, a chemical found in tobacco products. It develops as individuals repeatedly use tobacco, leading to physical and psychological reliance. Over time, the body becomes accustomed to nicotine, requiring more to achieve the same effects. This dependence can result in withdrawal symptoms when nicotine use is reduced or stopped. Symptoms may include irritability, anxiety, difficulty concentrating, and increased appetite. The condition often leads to continued tobacco use despite awareness of its harmful effects.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518135-10-00Protocol codeP150952JEstimated enrolment650 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).