Distress Tolerance Treatment for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Number of Participants With Biochemically Verified Smoking Abstinence
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.
详细描述
- 18-65 years of age,
- a regular smoker for at least one year,
- currently smoking 10 or more cigarettes per day,
- report motivation to quit smoking in the next month.
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 (Participant)
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
- •18-65 years old
- •regular smoker for at least one year
- •currently smoking 10 or more cigarettes per day
排除标准
- •Current Axis I disorder
- •Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
- •Current suicidal risk
- •Pregnancy or breast feeding
- •Use of nicotine replacement products or bupropion
研究组 & 干预措施
New Smoking Cessation Counseling
- One 60-minute individual session
- Seven 2-hour group sessions
- Two individual brief telephone contacts over an eight-week period.
- Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
干预措施: Transdermal Nicotine (Drug)
Standard Smoking Cessation Counseling
- One 60-minute individual session
- Seven 2-hour group sessions
- Two individual brief telephone contacts over an eight-week period.
- Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
干预措施: Transdermal Nicotine (Drug)
结局指标
主要结局
Number of Participants With Biochemically Verified Smoking Abstinence
时间窗: Six months
1. Carbon monoxide of expired air 2. Salivary cotinine level of saliva
次要结局
未报告次要终点