A Comparative Effectiveness RCT of Optimized Cessation Treatments
2020年5月11日 更新者：University of Wisconsin, Madison
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.
研究概览
地位
完全的
条件
详细说明
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
研究类型
介入性
注册 (实际的)
623
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Wisconsin
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Madison、Wisconsin、美国、53711
- University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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).
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8 weeks of nicotine patch
a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website
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实验性的：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.
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Nicotine lozenge prior to attempting to quit smoking
26 weeks of combination NRT as part of a quit smoking attempt
three 20-min In-person Cessation Counseling sessions
8 Maintenance-phase smoking cessation counseling sessions
11 brief, automated calls reminding them to use their medications properly
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Abstinence From Smoking
大体时间：6 months post treatment
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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).
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6 months post treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Megan Piper, PhD、University of Wisconsin, Madison
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年1月1日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2018年2月1日
研究注册日期
首次提交
2014年11月21日
首先提交符合 QC 标准的
2014年11月24日
首次发布 (估计)
2014年11月25日
研究记录更新
最后更新发布 (实际的)
2020年5月13日
上次提交的符合 QC 标准的更新
2020年5月11日
最后验证
2020年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.