Study Comparing Cytisinicline and Nicotine Therapy for Patients with Nicotine Dependence and Chronic Kidney Disease

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What is this study about?

This clinical trial is focused on helping people who are dependent on nicotine and also have Chronic Kidney Disease. The study will compare two treatments: a medication called Cytisine, which will be given in a prolonged dosage, and various forms of Nicotine Replacement Therapy (NRT). NRT includes products like Nicorette Invisipatch (a transdermal patch) and Nicorette Fruit and Coolmint lozenges, which are designed to help reduce nicotine cravings.

The purpose of the study is to assess and compare the effectiveness of these treatments over a period of six months. Participants will be randomly assigned to either the Cytisine group or the NRT group. The study will last for 12 weeks, during which participants will receive their assigned treatment. Throughout the study, participants will be monitored for their ability to abstain from smoking, as well as any withdrawal symptoms or side effects they may experience.

Participants will be asked to attend regular check-ups to evaluate their progress and any changes in their health. The goal is to determine whether Cytisine is as effective as NRT in helping people quit smoking, especially those with Chronic Kidney Disease. This study aims to provide valuable insights into the best ways to support individuals in overcoming nicotine dependence while managing their kidney health.

1 joining the study

Upon joining the study, the patient is randomly assigned to one of two groups: the study arm or the control group.

The study aims to compare the effectiveness of two treatments for nicotine dependence in patients with chronic kidney disease.

2 treatment initiation

The patient begins treatment with either cytisinicline or nicotine replacement therapy.

Cytisinicline is administered orally, while nicotine replacement therapy involves the use of transdermal patches and lozenges.

3 medication details

For nicotine replacement therapy, the patient may use the following products:

Nicorette Invisipatch (transdermal patch) available in 10 mg, 15 mg, and 25 mg dosages, applied for 16 hours daily.

Desmoxan (tablet) with a dosage of 1.5 mg, taken orally.

Nicorette Fruit and Nicorette Coolmint (compressed lozenges) with a dosage of 2 mg, taken orally.

4 monitoring and assessment

The patient’s progress is monitored at intervals of 7±2, 14±2, and 30±5 days after starting treatment.

The severity of withdrawal symptoms and any adverse events are assessed during these visits.

5 midpoint evaluation

After 3 months, the patient’s abstinence from tobacco products is evaluated.

Abstinence is defined as smoking no more than 5 cigarettes since the start of the study.

6 final evaluation

At the end of 6 months, the primary goal is to achieve abstinence from tobacco products.

The effectiveness of the treatment is compared between the study arm and the control group.

Who Can Join the Study?

The patient, whether a woman or a man, must want to participate in the study and be able to give written permission to join.
The patient must be aged 18 or older but younger than 65.
The patient must be a current daily cigarette smoker, meaning they smoke tobacco products every day or almost every day for at least 3 months.
The patient must be motivated and willing to try to quit smoking with medication, as determined in a conversation with the patient.
The patient must have chronic kidney disease at least stage 3. This means their kidneys are not filtering blood as well as they should, with a specific measure called glomerular filtration rate (eGFR) between 15 and 60 ml/min, and this condition must have lasted for at least 3 months before joining the study.
Women of reproductive age must: a) have a negative pregnancy test, which checks for a hormone called beta HCG in the urine; b) agree to use a highly effective method of birth control during the treatment.
The patient must have access to a telephone.

Who Cannot Join the Study?

People who are dependent on nicotine cannot participate. Nicotine dependence means having a strong need to use nicotine, which is found in cigarettes and some other products.
Individuals with Chronic Kidney Disease are excluded. Chronic Kidney Disease is a condition where the kidneys do not work as well as they should over a long period.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	02.09.2024

Trial locations

Investigated drugs:

Cytisine is a medication used to help people stop smoking. It works by reducing the craving for nicotine and easing withdrawal symptoms. In this trial, it is being tested to see if it is as effective as other treatments for people with nicotine dependence, especially those who have chronic kidney disease.

Nicotine Replacement Therapy involves using products that provide low doses of nicotine, without the harmful chemicals found in tobacco smoke. This helps to reduce withdrawal symptoms and cravings, making it easier for people to quit smoking. In this trial, it serves as a comparison to see how well it works against Cytisine in helping people with chronic kidney disease stop smoking.

Investigated diseases:

Nicotine Dependence – This condition is characterized by an addiction to nicotine, a chemical found in tobacco products. Individuals with nicotine dependence often experience strong cravings for nicotine and may find it difficult to quit smoking or using tobacco. The addiction can lead to a cycle of repeated use, withdrawal symptoms, and relapse. Over time, the body becomes accustomed to nicotine, requiring more to achieve the same effects. Withdrawal symptoms can include irritability, anxiety, and difficulty concentrating. The condition can significantly impact daily life and health.

Chronic Kidney Disease – This disease involves the gradual loss of kidney function over time. The kidneys, which filter waste and excess fluids from the blood, become less effective, leading to a buildup of waste in the body. Symptoms may not appear until the disease is advanced and can include fatigue, swelling in the legs and ankles, and changes in urination. The progression of the disease can vary, with some individuals experiencing a slow decline in kidney function. As the disease advances, it can lead to complications such as high blood pressure and anemia. Regular monitoring and lifestyle changes are often necessary to manage the condition.

Trial ID:

2023-509235-39-00

Protocol code:

SCARP

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Cytisinicline and Nicotine Therapy for Patients with Nicotine Dependence and Chronic Kidney Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?