Cytisine in prolonged dosage versus Nicotine Replacement Therapy in nicotine-dependent patients with Chronic Kidney Disease - single-center, randomized, non-inferiority clinical trial.
Key facts
- Where
- Warsaw, LengyelországSee the site
- Phase
- 4. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Lengyelország
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu MedycznegoWarsaw, LengyelországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Trial code
- EU 2023-509235-39-00
- Record updated
- 2024. július 29.
- Original description
Assessment and comparison of the efficacy of treatment in study arm and control group in 6 months.Read full original descriptionShow less
Assessment and comparison of the efficacy of treatment in study arm and control group in 6 months.
Inclusion: Patient (woman or man) who wants to participate in the study and is able to give a written informed consent; Age over or equal to 18 and under 65; Current daily cigarette smoker - a person who smokes tobacco products every day or almost every day for at least 3 months; Motivation and willingness to try to quit smoking with medication, assessed in conversation with the patient; Chronic kidney disease at least stage 3, defined as impaired glomerular filtration eGFR MDRD < 60 ml/min and > 15 ml/min persisting for at least 3 months preceding qualification for the study; Women of reproductive age: a) exclusion of pregnancy by testing the concentration of beta HCG in the urine; b) consent to use a highly effective method of contraception during treatment; Telephone access.
Exclusion: Treatment in the last 4 weeks with other smoking cessation medications (bupropion, varenicline, nortriptyline); Participation in another clinical trial of the drug in the 4 weeks before randomization; Recent history of myocardial infarction, stroke, heart failure requiring hospitalization (within 3 months before randomization); Hypersensitivity to cytisine or any of the excipients or nicotine preparations; Currently uncontrolled hypertension above 160/100 mm Hg; Documented diagnosis of: schizophrenia, bipolar psychoaffective disorder, epilepsy, symptoms of moderate to severe depression; Biochemical features of liver damage (AST/ALT > 2x above normal); Pheochromocytoma of the adrenal glands; Current other addiction (alcohol, other psychoactive substances); Pregnancy or breastfeeding; Male or female persons of childbearing potential who do not consent to the use of adequate birth control methods during the study treatment period.