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Cytisine in prolonged dosage versus Nicotine Replacement Therapy in nicotine-dependent patients with Chronic Kidney Disease - single-center, randomized, non-inferiority clinical trial.
EU CTIS ID: 2023-509235-39-00
What this study is testing
Assessment and comparison of the efficacy of treatment in study arm and control group in 6 months.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Hypersensitivity to cytisine or any of the excipients or nicotine preparations.
- 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.
- Biochemical features of liver damage (AST/ALT > 2x above normal).
- Currently uncontrolled hypertension above 160/100 mm Hg.
- Recent history of myocardial infarction, stroke, heart failure requiring hospitalization (within 3 months before randomization).
See the full eligibility criteria
- 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.
- Hypersensitivity to cytisine or any of the excipients or nicotine preparations.
- 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.
- Biochemical features of liver damage (AST/ALT > 2x above normal).
- Currently uncontrolled hypertension above 160/100 mm Hg.
- Recent history of myocardial infarction, stroke, heart failure requiring hospitalization (within 3 months before randomization).
- Pheochromocytoma of the adrenal glands.
- Documented diagnosis of: schizophrenia, bipolar psychoaffective disorder, epilepsy, symptoms of moderate to severe depression
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.