Efficacy of Cognitive Behaviour Therapy Associated to Nicotine Replacement in Tobacco Cessation: a Randomised Open Label Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Smoking cessation
研究概览
简要总结
Background: Pharmacological strategies to improve smoking cessation have been largely studied. The efficacy of cognitive behavior therapy associated to nicotine replacement in tobacco cessation has not yet been demonstrated.
Objective: Evaluate if cognitive behavior therapy during six weeks associated to nicotine replacement for twelve weeks is able to contribute to tobacco cessation at the end of 52 weeks.
Methods: Multicentre, open-label, and pragmatic randomized controlled trial will include 334 patients. Analysis will follow intention-to-treat principle.
Patients older than 18 years old and who had smoked at least 5 cigarettes in the past year before randomization will be included.
All of them will receive nicotine replacement therapy with patches and gum. They will be randomized 1:1 ratio to attend or not cognitive behavior therapy once a week for the first six weeks of the treatment. Every two weeks all of the patients will be evaluated by a physician in order to access any adverse effects from the nicotine replacement.
All patients will have carbon monoxide levels accessed at baseline and after 6 weeks. Telephonic interview will be done at 16, 28, and 52 weeks to access the rates of tobacco cessation, relapses episodes and abstinence maintenance.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smokers (≥ 5 cigarettes/day during the previous year) who had not had a period of abstinence greater than 3 months before randomization
- •Age ≥ 18 years < 75 years;
- •Capable of reading and understanding Portuguese;
- •Willing to quit smoking.
排除标准
- •Dementia;
- •Alcoholism;
- •Regular use of illicit drugs;
- •Panic disorders;
- •Psychosis;
- •Current pregnancy;
- •History of bipolar disturbance;
- •Contraindication to nicotine patches;
- •Prior use of bupropion and/or varenicline in the previous 12 months before randomization;
- •Patients who refused to provide informed consent;
研究组 & 干预措施
Cognitive behavior therapy
Cognitive behavior therapy for 6 weeks associated to nicotine replacement for 12 weeks
干预措施: Cognitive behavioral therapy in group (Behavioral)
Cognitive behavior therapy
Cognitive behavior therapy for 6 weeks associated to nicotine replacement for 12 weeks
干预措施: Nicotine replacement (Drug)
Nicotine replacement
Nicotine replacement for 12 weeks
干预措施: Nicotine replacement (Drug)
结局指标
主要结局
Smoking cessation
时间窗: 52 weeks
次要结局
- Levels of anxiety(6 weeks)
- Levels of depression(6 weeks)
- Smoking Relapse rates(52 weeks)