Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
研究概览
简要总结
Smoking remains the single most preventable cause of morbidity and mortality in the United States, accounting for approximately half a million deaths every year. The current study will investigate the efficacy and mechanisms of change of a novel smoking cessation intervention. The current study will thus provide essential information regarding a treatment that has the potential to enhance the efficacy of existing smoking cessation interventions, thereby having a beneficial impact on the public health of the United States.
详细描述
Cigarette smoking remains the single most preventable cause of mortality and morbidity in the United States. Long-term abstinence rates for even the most rigorous of smoking cessation treatments range between 20% and 35%. It is therefore essential that research continue to investigate novel smoking cessation interventions. Leading contemporary theories of addiction motivation posit that the escape or avoidance of negative affect withdrawal (NAW) symptoms (e.g., anger, anxiety, and depression/sadness) constitutes a strong motivational basis for cigarette smoking and plays a critical role in relapse to cigarette use. However, whereas NAW symptoms appear to exert a powerful influence on smoking cessation treatment outcome, smoking cessation interventions may exert only modest effects on NAW symptoms. Accordingly, it has been proposed that smoking cessation interventions may be augmented by aiding smokers in the practice of NAW regulation strategies. The primary goal of this investigation is to evaluate an early withdrawal exposure plus NAW regulation training intervention for smoking cessation. Specific aims include evaluating the efficacy of the treatment components and investigating potential mediators and moderators of the treatment components. Participants will be adult smokers (N = 400) of at least 5 cigarettes per day with the intention to quit smoking. Using a factorial design, participants will be randomized to early withdrawal exposure (yes vs. no) and behavioral intervention (NAW regulation training vs. relaxation control training), resulting in four distinct conditions. The investigator's primary hypothesis is that early withdrawal exposure plus NAW regulation training will produce higher rates of seven-day point-prevalence abstinence at 1, 3, and 6 months after end-of-treatment, suggesting a synergistic (i.e., non-additive) effect of the two intervention components. Mediators (e.g., in-session withdrawal symptoms) and moderators (e.g., demographic characteristics, tobacco dependence) will be investigated via established analyses. These data will advance the experimental intervention with a focus on targeting mechanisms of change as well as participant characteristics to which the intervention may be tailored. The experimental intervention described in the current proposal has the potential to ultimately enhance the efficacy of existing smoking cessation interventions and will therefore contribute uniquely to the field.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 18 years of age
- •smoke at least 5 cigarettes per day
- •Expired breath carbon monoxide (CO) reading of at least five parts per million
- •report the intention to quit
- •reside in the Birmingham area with no plan to relocate outside of the area in the next 6 months
- •access to a telephone
排除标准
- •inability to speak English
- •presence of a condition that contraindicates use of the nicotine patch
- •presence of conditions that might interfere with compliance with the protocol or greatly complicate treatment
- •any acutely life-threatening disease
- •concurrent participation in a formal treatment program for smoking cessation
- •current use of any pharmacotherapy for smoking cessation
研究组 & 干预措施
Early Withdrawal Exposure plus NAW Regulation Training
The development, application, modification, and repeated practice of individualized withdrawal regulation strategies (e.g., behavioral and cognitive strategies for allaying withdrawal symptoms) across the first 4 hours of abstinence over 4 separate sessions.
干预措施: cognitive-behavioral withdrawal regulation strategies (Behavioral)
Early Withdrawal Exposure plus NAW Regulation Training
The development, application, modification, and repeated practice of individualized withdrawal regulation strategies (e.g., behavioral and cognitive strategies for allaying withdrawal symptoms) across the first 4 hours of abstinence over 4 separate sessions.
干预措施: early withdrawal exposure (Behavioral)
Early Withdrawal Exposure plus Relaxation Control Training
The development, application, modification, and repeated practice of relaxation strategies across the first 4 hours of abstinence over 4 separate sessions.
干预措施: relaxation strategies (Behavioral)
Early Withdrawal Exposure plus Relaxation Control Training
The development, application, modification, and repeated practice of relaxation strategies across the first 4 hours of abstinence over 4 separate sessions.
干预措施: early withdrawal exposure (Behavioral)
NAW Regulation Training Only
The development, application, modification, and repeated practice of individualized withdrawal regulation strategies (e.g., behavioral and cognitive strategies for allaying withdrawal symptoms) over 4 separate sessions involving smoking as usual.
干预措施: cognitive-behavioral withdrawal regulation strategies (Behavioral)
Relaxation Control Training Only
The development, application, modification, and repeated practice of relaxation strategies over 4 separate sessions involving smoking as usual.
干预措施: relaxation strategies (Behavioral)
结局指标
主要结局
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
时间窗: 6 months after end-of-treatment
Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
时间窗: 1 month after end-of-treatment
Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
时间窗: 3 months after end-of-treatment
Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less
次要结局
- Physical tobacco dependence(6 months after end-of-treatment)
- Abstinence-related expectancies(6 months after end-of-treatment)
- Thoughts about abstinence(6 months after end-of-treatment)
- Motivational tobacco dependence(6 months after end-of-treatment)
- Withdrawal symptoms(6 months after end-of-treatment)
- Intolerance for smoking abstinence discomfort(6 months after end-of-treatment)
- Cessation milestones as determined by the Timeline Followback Interview(6 months after end-of-treatment)
- Cessation milestones as determined by the Timeline Followback Interview(1 month after end-of-treatment)
- Cessation milestones as determined by the Timeline Followback Interview(3 months after end-of-treatment)
- Physical tobacco dependence(1 month after end-of-treatment)
- Physical tobacco dependence(3 months after end-of-treatment)
- Motivational tobacco dependence(1 month after end-of-treatment)
- Motivational tobacco dependence(3 months after end-of-treatment)
- Withdrawal symptoms(1 month after end-of-treatment)
- Withdrawal symptoms(3 months after end-of-treatment)
- Abstinence-related expectancies(1 month after end-of-treatment)
- Abstinence-related expectancies(3 months after end-of-treatment)
- Thoughts about abstinence(1 month after end-of-treatment)
- Thoughts about abstinence(3 months after end-of-treatment)
- Intolerance for smoking abstinence discomfort(1 month after end-of-treatment)
- Intolerance for smoking abstinence discomfort(3 months after end-of-treatment)
研究者
Peter Hendricks
University Professor
University of Alabama at Birmingham
