Smoking Cessation And Reduction in Depression
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Smoking Cessation
研究概览
简要总结
It is well established in studies across several countries that tobacco smoking is more prevalent among depressed patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in depressed smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population.
We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in depressed smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product.
Outcome measures: A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). Abstinence from smoking will be calculated at each study visit ("quitters"). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders".
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Major Depressive Disorder (MDD) (according to DSM 5 criteria) from throughout Sicily (Italy), who smoke tobacco cigarettes.
- •smoke ≥10 factory made cig/day, for at least the past five years
- •age 18-65 years
- •in good general health (in absence of cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis )
- •not currently attempting to quit smoking or wishing to do so in the next 30 days (a specific test will be included to check their unwillingness to quit) 6 months
- •committed to follow the trial procedures.
排除标准
- •use of smokeless tobacco or nicotine replacement therapy or other smoking cessation therapies
- •pregnancy or breastfeeding
- •current or recent (less than 1 yr) past history of alcohol and/or drug abuse
- •active suicidal intention
- •other significant co-morbidities according to the Investigator's clinical assessment (e.g. cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis
研究组 & 干预措施
eCig 24 mg nicotine
eCig 24 mg nicotine for 12 weeks
干预措施: Ecig 24 mg nicotine (Device)
Ecig 0 mg nicotine
eCig 0 mg nicotine for 12 weeks
干预措施: Ecig 0 mg nicotine (Device)
Nicotine free inhalator
nicotine free inhalator for 12 weeks
干预措施: Nicotine free inhalator (Device)
结局指标
主要结局
Smoking Cessation
时间窗: 52 weeks
Abstinence from smoking, defined as complete self-reported abstinence from tobacco smoking - not even a puff (together with an eCO concentration of ≤7 ppm), will be calculated at each study visit ("quitters").
次要结局
- Smoking reduction(52 weeks)
研究者
Riccardo Polosa
Full Professor of internal medicine
Universita degli Studi di Catania