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临床试验/NCT04015414
NCT04015414已完成3 期

Varenicline Versus Cytisine for Smoking Cessation in the Primary Care Setting in Croatia and Slovenia - a Randomized Controlled Trial

University of Zagreb2 个研究点 分布在 2 个国家目标入组 352 人开始时间: 2020年7月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
352
试验地点
2
主要终点
Seven day abstinence from tobacco

研究概览

简要总结

The overall goals of this study are to 1) assess awareness of interest in the use of pharmacotherapy for smoking cessation in Croatia and Slovenia, countries in Central Europe with very high smoking prevalence, and 2) investigate whether cytisine is at least as feasible and effective as varenicline in helping smokers to quit in a real-life setting: family medicine practices in Croatia and Slovenia. The investigators propose to survey patients from 40 primary care practices (20 in Croatia and 20 in Slovenia) to assess desire to quit smoking and awareness and interest in pharmacotherapy. Additionally, 380 patients with interest in quitting smoking will be randomly assigned to use varenicline or cytisine to help quit smoking.

The investigators hypothesize that cytisine is at least as feasible and effective as varenicline in helping smokers from primary care practices in Croatia and Slovenia to quit smoking.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Receive care in one of forty family medicine practices in Croatia and Slovenia
  • Aged 18 or older
  • Current smokers
  • Indicate a desire to stop smoking and to use pharmacotherapy.

排除标准

  • Mental illness who cannot provide informed consent for the study
  • Pregnant or breastfeeding.

研究组 & 干预措施

Varenicline (Champix)

Active Comparator

Varenicline treatment will start one week prior to the patient's target quit date at 0.5 mg/day for days 1-3, 0.5 mg twice daily for days 4-7. On the target quit date (day 8), the dose will be increased to 1 mg twice daily and maintained for day 8-week 12. Patients will receive weekly calls during the first 4 weeks and at weeks 8, 12, and 24 to inquire about medication adherence and smoking status, motivate the patient to take the medication, encourage them not to smoke, and ask about possible side effects or other issues.

干预措施: Varenicline (Drug)

Cytisine (Tabex)

Active Comparator

Patients will be asked to reduce their smoking during the first 4 days of treatment with aim to quit on the 5th day (target quit date). Cytisine treatment will follow standard manufacturer's dosing protocol of one tablet every 2 hours through the waking day (up to 6 tablets per day) for days 1-3, one tablet every 2.5 hours (up to 5 tablets per day) for days 4-12, one tablet every 3 hours (up to 4 tablets per day) for days 13-16, one tablet every 4-5 hours (3 tablets per day) for days 17-20, and one tablet every 6 hours (2 tablets per day) for days 21-25.

干预措施: Cytisine (Drug)

结局指标

主要结局

Seven day abstinence from tobacco

时间窗: 12-weeks following target quit date

Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.

次要结局

  • Seven day abstinence from tobacco(4, 8, 12, and 24 weeks following target quit date)
  • Continuous smoking cessation(4, 8, 12, and 24 weeks following target quit date)
  • Medication adherence(1, 2, 3, 4, 8, 12 weeks following target quit date)
  • Seven day abstinence from tobacco country and practice(4-weeks following target quit date)
  • Side effects(4, 8, 12, and 24 weeks following target quit date)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stjepan Oreskovic

Full Professor

University of Zagreb

研究点 (2)

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