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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Hospital De Galdakao Usansolo Galdakao Spain
Hospital Clinic De Barcelona Barcelona Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Universitario Virgen De La Victoria Malaga Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.05.2025

Trial locations

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.

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 ID:
2024-518936-36-00
Protocol code:
CITISILONG
Trial Phase:
Therapeutic confirmatory (Phase III)

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