Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Safety and Effectiveness of Cytisinicline for Helping Smokers Quit

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 are active smokers and want to quit smoking. The study is testing a treatment called cytisinicline, which is taken as a film-coated tablet. Cytisinicline is a chemical substance that may help people stop smoking by reducing their cravings for cigarettes.

The purpose of the study is to evaluate the safety and effectiveness of cytisinicline when used for different lengths of time. Participants will be randomly assigned to one of three groups, each receiving cytisinicline for either 25, 50, or 75 days. The study will observe how well the treatment works and how safe it is over these different periods. Participants will be monitored at various points during the study to see if they have stopped smoking and to check for any side effects.

The trial will take place over several months, with follow-up checks at 3, 6, and 12 months to assess the participants' progress in quitting smoking. The study aims to provide valuable information on the best way to use cytisinicline to help people quit smoking safely and effectively.

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 trial

    Upon joining the trial, you will be randomly assigned to one of the three groups. Each group will receive a different duration of treatment with cytisinicline.

    The groups will receive treatment for either 25, 50, or 75 days. This assignment is random and cannot be chosen.

  2. Step 2

    Medication administration

    You will take cytisinicline in the form of a film-coated tablet. The medication is taken orally, which means you will swallow the tablet.

    The dosage is 1.5 mg per tablet. The frequency and exact schedule of taking the medication will be provided to you by the study team.

  3. Step 3

    Treatment duration

    Depending on the group you are assigned to, the treatment will last for 25, 50, or 75 days.

    During this period, you will continue to take the medication as instructed.

  4. Step 4

    Follow-up assessments

    You will have follow-up assessments to evaluate your progress. These assessments will occur at 3, 6, and 12 months after starting the trial.

    The assessments will focus on your ability to abstain from smoking and any side effects you may experience.

  5. Step 5

    Safety monitoring

    Throughout the trial, your safety will be monitored. This includes checking for any side effects from the medication.

    You will be asked to report any unusual symptoms or health changes to the study team.

Who can join the trial?

4 criteria

  • Men and women who are of legal age (adults).
  • Smoke more than 10 cigarettes a day for the last year and during the last month before the screening visit.
  • Be prepared and motivated to quit smoking, with a score of 7 or higher on a visual analog motivation scale (a simple tool to measure how motivated you are).
  • Have not used any medication for nicotine dependence, such as nicotine replacement therapy (like patches or gum), varenicline, bupropion, or cytisinicline, in the last 3 months.

Who cannot join the trial?

1 criterion

  • People who are active smokers cannot participate. This means if you currently smoke cigarettes or use tobacco products, you are not eligible.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Cytisinicline is a medication used to help people stop smoking. It works by reducing the craving for nicotine and easing withdrawal symptoms. In this clinical trial, researchers are studying how effective and safe it is when used for different lengths of time. The goal is to see if taking cytisinicline for a longer period can help more people quit smoking successfully compared to the usual treatment duration.

What is already known about the treatment

Cytisinicline – Cytisinicline is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in helping people quit smoking. It is a well-known substance in medical literature, particularly for its potential in smoking cessation therapies. The main therapeutic indication for cytisinicline is to assist active smokers in quitting smoking. At the molecular level, cytisinicline works by binding to nicotine receptors in the brain, reducing the craving for nicotine and easing withdrawal symptoms. It is classified pharmacologically as a partial agonist of nicotinic acetylcholine receptors.

Investigated diseases

Tobacco Use Disorder – Tobacco Use Disorder is a condition characterized by the compulsive use of tobacco products, primarily cigarettes, despite the harmful consequences. It often begins with occasional use and can progress to regular, heavy consumption. Over time, individuals may develop a tolerance, requiring more tobacco to achieve the same effects. Withdrawal symptoms, such as irritability, anxiety, and cravings, can occur when attempting to reduce or stop use. The disorder can lead to significant health issues, including respiratory and cardiovascular problems. It is a chronic condition that can persist for many years without intervention.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518936-36-00Protocol codeCITISILONGEstimated enrolment400 patientsSponsorFundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).