Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Biochemically Validated Continuously Abstinence
研究概览
简要总结
This proposed project is to assess the efficacy of CBT-based digital smoking cessation interventions in China, as well as explore its neuroimaging mechanisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Use cigarettes for no less than 1 year, and use cigarettes ≥ 10 per day
- •Nicotine dependence (FTCD ≥ 3)
- •Willing to make an attempt to quit smoking in the next month, and have not quit smoking in the past 3 months, and .
- •No other addictions except nicotine
- •Education level of junior high school or above
- •Age between 18 to 45 years old
- •Right-handed
- •No contraindication of MRI scanning
- •Willing to provide informed consent to participate in the study.
排除标准
- •Patients who are receiving medication
- •Previous and current mental disorders,and/or mental disorders in line with DSM-5 diagnostic criteria in two departments and three generations.
- •Brain organic disease, brain injury history, coma history
- •Serious physical disease, endocrine disease history, abnormal blood picture, heart, liver and kidney function after examination
- •Pregnant and lactating women
结局指标
主要结局
Biochemically Validated Continuously Abstinence
时间窗: 4 weeks
Biochemical validation of 4-week continuous smoking abstinence by urine cotinine test.
Brain Structural Characteristics
时间窗: 4 weeks
Differences of brain structure between successful and unsuccessful smokers after intervention, which will be measured by white matter volume, gray matter volume, cortical thickness, and surface area.
Brain Functional activity
时间窗: 4 weeks
Differences of whole brain function activity between successful and unsuccessful smokers after intervention, which will be measured by ReHo, ALFF, fALFF, and functional connectivity (FC)
次要结局
- Self-reported 7-day Point Abstinence(4 weeks)
- Self-reported Continuous Abstinence(4 weeks)
研究者
Yanhui Liao
Deputy Chief Physician
Sir Run Run Shaw Hospital