A Comparative Effectiveness RCT of Optimized Cessation Treatments
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 623
- 试验地点
- 1
- 主要终点
- Number of Participants With Abstinence From Smoking
研究概览
简要总结
This study is a 2-arm randomized clinical trial (RCT). Participants motivated to quit smoking will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2) Abstinence-Optimized Cessation Treatment (AOCT). The components for the optimized treatment have strong theoretical and empirical support from the investigators previous screening studies.
详细描述
The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop treatments for smokers not yet ready to quit, those who are preparing to quit, those actively engaged in the quitting process and those who have tried to quit but relapsed. To achieve this goal, this research comprises three distinct research studies, each of which represent a phase in a comprehensive chronic care treatment model for clinical intervention with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term Quitting Study. The goal of each study is to test and identify effective intervention components for distinct phases of the smoking cessation process. These components will then be combined for future research on the effectiveness of this chronic care treatment package
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >=18 years
- •smoking >4 cigarettes/day for the previous 6 months
- •able to read, write, and speak English
- •have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts
- •and if currently using NRT, agreeing to use only study medication for the duration of the study
- •we will not exclude participants based on their prior use of cessation medication or if they use multiple tobacco products in order to enhance real-world generalization (these will be statistically controlled in analyses)
- •not currently attempting to quit smoking
- •not intending to quit smoking (defined as no plans to quit in the next month)
- •and planning to remain in the intervention catchment area for at least 12 months.
排除标准
- •currently taking bupropion or varenicline
- •medical contraindications to using NRT including hospitalized (for at least one night) for a stroke, heart attack, congestive heart failure or diabetes in the last 30 days
- •diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years
- •and, if the participant is a woman of childbearing potential, being pregnant or intending to becoming pregnant or unwillingness to use an approved method of birth control during treatment.
研究组 & 干预措施
Abstinence-Optimized Cessation Treatment
There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.
干预措施: Intensive In-Person Cessation Counseling (Behavioral)
Modern Usual Care
Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).
干预措施: Nicotine patch (Drug)
Modern Usual Care
Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).
干预措施: in-person counseling and quitline counseling (Behavioral)
Abstinence-Optimized Cessation Treatment
There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.
干预措施: Preparation Nicotine Mini-Lozenges (Drug)
Abstinence-Optimized Cessation Treatment
There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.
干预措施: Combination NRT (nicotine patch + nicotine mini-lozenges) (Drug)
Abstinence-Optimized Cessation Treatment
There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.
干预措施: Extended Maintenance Counseling Calls (Behavioral)
Abstinence-Optimized Cessation Treatment
There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.
干预措施: Automated Adherence Calls (Behavioral)
结局指标
主要结局
Number of Participants With Abstinence From Smoking
时间窗: 6 months post treatment
The outcome measure consists of the number of participants reporting abstinence from smoking at 6 months that is biochemically confirmed (exhaled carbon monoxide \< 6 parts per million).
次要结局
未报告次要终点