BridgeMD
Phase IV, randomized, open-label, open-label, controlled, parallel, multicenter clinical trial in patients who are candidates for smoking cessation to evaluate the safety and efficacy of citisinicline maintenance therapy.
EU CTIS ID: 2024-518936-36-00
What this study is testing
The general objective of this study is to evaluate the efficacy, safety and economic impact of two prolonged regimens of cytisinicline (50 and 75 days in duration) and Compare them with the usual regimen (25 days).
- 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
- Men and women of legal age who smoke more than 10 cigarettes a day during the last year and during the last month of the screening visit.
- Be prepared and motivated to quit smoking (have a score on the visual analog motivation scale greater than or equal to 7).
- Not having been on pharmacological treatment for nicotine dependence (nicotine replacement therapy [NRT], varenicline, bupropion or cytisinicline) during the last 3 months.
You likely can't join if
- Kidney and/or liver failure.
- Patients receiving treatment with antituberculosis drugs.
- Patients receiving drugs metabolized by the CYP1A2 and CYP1A1 enzyme, especially those with a narrow therapeutic range (e.g., theophylline, tacrine, clozapine, and ropinirole).
- Women treated with systemic hormonal contraceptives.
- Pregnant or breastfeeding women.
- Over 65 years of age (due to limited clinical experience).
See the full eligibility criteria
- Men and women of legal age who smoke more than 10 cigarettes a day during the last year and during the last month of the screening visit.
- Be prepared and motivated to quit smoking (have a score on the visual analog motivation scale greater than or equal to 7).
- Not having been on pharmacological treatment for nicotine dependence (nicotine replacement therapy [NRT], varenicline, bupropion or cytisinicline) during the last 3 months.
- Kidney and/or liver failure.
- Patients receiving treatment with antituberculosis drugs.
- Patients receiving drugs metabolized by the CYP1A2 and CYP1A1 enzyme, especially those with a narrow therapeutic range (e.g., theophylline, tacrine, clozapine, and ropinirole).
- Women treated with systemic hormonal contraceptives.
- Pregnant or breastfeeding women.
- Over 65 years of age (due to limited clinical experience).
- Hypersensitivity to the active ingredient or to any of the excipients.
- Unstable angina.
- Recent personal history of acute myocardial infarction or recent stroke (less than 8 weeks).
- Arrhythmias with clinical relevance or uncontrolled arterial hypertension.
- History of psychiatric illness with and without treatment (panic disorder, psychosis, bipolar disorder, depression) in the last 12 months.
- History of alcohol or other drug abuse in the last 12 months.
- Use of tobacco products other than cigarettes, e-cigarettes, or marijuana in the past month and did not agree to abstain from using these products during study participation.
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, 65+ years, 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.