2024-518936-36-00招募中4 期
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.
Fundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela10 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年5月5日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 10
- 主要终点
- It will be carried out by evaluating punctual and continuous abstinence at 3, 6 and 12 months.
研究概览
简要总结
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).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
It will be carried out by evaluating punctual and continuous abstinence at 3, 6 and 12 months.
It will be carried out by evaluating punctual and continuous abstinence at 3, 6 and 12 months.
The safety results will be carried out by evaluating the incidence of the side effects foreseen in the technical data sheet.
The safety results will be carried out by evaluating the incidence of the side effects foreseen in the technical data sheet.
次要结局
未报告次要终点
研究者
Carlos Rábade Castedo
Scientific
Fundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela
研究点 (10)
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