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Study on Cytisine for Quitting Nicotine E-Cigarettes and Tobacco in Motivated Individuals

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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 quit using nicotine-containing electronic cigarettes and tobacco cigarettes. The study is testing a treatment called cytisine, which is a chemical substance used in a tablet form. Participants in the study will receive either cytisine or a placebo, which looks like the cytisine tablet but does not contain the active substance. Both groups will also receive support to help them quit smoking or vaping.

The purpose of the study is to evaluate how effective cytisine is in helping people stop using electronic cigarettes and tobacco cigarettes. Participants who are motivated to quit will be divided into two groups. One group will take cytisine tablets for 12 weeks, while the other group will take placebo tablets for the same period. Both groups will receive behavioral support to assist them in quitting. The study will monitor participants for 30 weeks to see if they can remain smoke-free and vape-free.

Throughout the study, participants will be asked to report their progress and may undergo tests to confirm they have stopped using nicotine products. The goal is to see if cytisine, combined with support, can help people quit smoking and vaping more effectively than support alone. This study aims to provide valuable information on the potential benefits of cytisine for those looking to quit nicotine use.

The research process

The trial runs in 4 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 two groups: the intervention group or the comparator group.

    The intervention group receives a 12-week course of 1.5 mg cytisine tablets along with behavioral support.

    The comparator group receives a 12-week course of placebo tablets, which look like cytisine tablets, along with behavioral support.

  2. Step 2

    Treatment period

    Participants take the assigned tablets orally as per the study protocol for a duration of 12 weeks.

    Behavioral support is provided throughout the treatment period to assist with cessation of electronic cigarettes (EC) containing nicotine and tobacco cigarettes (TC).

  3. Step 3

    Follow-up and monitoring

    Participants are monitored for continuous abstinence from EC and TC for 26 weeks preceding the 30-week follow-up.

    Abstinence is verified through biochemical tests, including urine tests for cotinine and NNAL, which are substances that indicate nicotine use.

    Participants self-report their abstinence status and any use of EC or TC during the study period.

  4. Step 4

    Outcome assessment

    The primary outcome is the biochemically verified continuous abstinence from EC and TC for 26 weeks before the 30-week follow-up.

    Secondary outcomes include self-reported abstinence at various intervals and the prevalence of abstinence during the study.

Who can join the trial?

12 criteria

  • Must be over 18 years old at the time of the screening visit.
  • Must agree to follow all study requirements and complete all study procedures.
  • Women who can have children must use a **highly effective method of birth control** during the study. This includes options like birth control pills, implants, injections, double barrier methods (like condoms with spermicide), intrauterine devices (IUDs), vaginal rings, complete abstinence, or contraceptive patches.
  • Men must use barrier contraception and ensure their partners use effective birth control methods.
  • Must be willing to use a mobile application during the treatment period, with the option to stop using it during the study.
  • Must provide a valid mobile phone number and a valid email address.
  • Must give written consent to participate in the study, including consent for screening, baseline, and follow-up visits after the trial.
  • Must have daily access to a mobile phone.
  • For **single EC users**: Must currently use electronic cigarettes (EC) with nicotine daily or at least five days a week for at least one month before the screening visit. Must not have used tobacco in any form in the past three months, verified by a carbon monoxide (CO) concentration of 5 parts per million (ppm) or less in exhaled air.
  • For **dual EC and TC users**: Must currently use EC with nicotine daily or at least five days a week for at least one month before the screening visit and smoke at least one tobacco cigarette (TC) per day. Must have a CO concentration in exhaled air greater than 5 ppm.
  • Must be willing to attempt quitting using the study products (cytisine or placebo).
  • Must be able and willing to complete all study visits.

Who cannot join the trial?

5 criteria

  • Individuals who are not motivated to quit using **electronic cigarettes** (also known as **vaping**) or **tobacco cigarettes** (also known as **smoking**).
  • Individuals who are not within the specified age range for the study.
  • Individuals who are part of a vulnerable population that the study is not designed to include.
  • Individuals who do not meet the health criteria required for participation in the study.
  • Individuals who are not able to follow the study procedures or take the study medication as required.
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Investigated drugs

Cytisine is a medication used in this trial to help people stop using nicotine-containing electronic cigarettes and tobacco cigarettes. It is given as a 12-week course of tablets. The goal is to see if cytisine, combined with behavioral support, can help participants quit smoking or vaping more effectively than a placebo.

What is already known about the treatment

Cytisine – Cytisine is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential to help individuals quit using nicotine-containing electronic cigarettes and tobacco cigarettes. The main therapeutic indication is to aid in smoking cessation, particularly for those motivated to stop using electronic cigarettes or both electronic and tobacco cigarettes. At the molecular level, cytisine works by binding to nicotinic acetylcholine receptors in the brain, which helps reduce withdrawal symptoms and cravings associated with nicotine addiction. It is classified pharmacologically as a partial agonist of nicotinic acetylcholine receptors.

Investigated diseases

Electronic Cigarette Cessation – This condition involves the process of quitting the use of electronic cigarettes, which are devices that deliver nicotine through vapor rather than smoke. Individuals who use electronic cigarettes may develop a dependency on nicotine, similar to traditional tobacco products. The cessation process can be challenging due to withdrawal symptoms and cravings for nicotine. Over time, with the right support and interventions, individuals can reduce their reliance on electronic cigarettes. The goal is to achieve a state where the individual no longer uses electronic cigarettes and can maintain this abstinence. This process often involves behavioral support and, in some cases, pharmacological aids to help manage withdrawal symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504708-27-00Protocol codeCYT03-2021Estimated enrolment600 patientsSponsorUniversity of Rzeszow

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