Evaluation of Learning-Theory-Based Smoking Cessation Strategies
2022年3月30日 更新者：Danielle E. McCarthy, Ph.D.、Rutgers University
This clinical trial tested whether a new treatment designed to help smokers prepare to quit smoking by practicing quitting several times helped more smokers quit and stay quit than standard treatment with nicotine patch and smoking cessation counseling.
The practice quitting treatment tested involved quitting for progressively longer periods of time tailored to individual patterns of smoking.
This clinical trial also tested whether non-nicotine cigarettes can help smokers become smoke free after slipping during a stop smoking attempt.
研究概览
地位
完全的
条件
详细说明
Participants in this study are randomized to one of two treatments conditions prior to a target quit date.
- One-half of participants will be randomly assigned to receive standard smoking cessation treatment comprising a 6-week supply of 21-mg nicotine patches and 4 individual smoking cessation counseling sessions.
- The other one-half of participants will be randomly assigned to receive standard treatment (patch and counseling, as above) plus to practice quitting 7 times over the 2.5 weeks leading up to a quit attempt. Practice quitting will involve not smoking for a period of time tailored to each individual's smoking pattern.
- All participants are asked to attend a 2-hour orientation session, complete 8 brief (5-minute) telephone calls and 9 longer(20-minute) telephone surveys over 3.5 weeks, attend a 30-minute office visit, and complete two 15-minute follow-up calls.
- All participants are also asked to report on their emotions, thoughts, and behaviors 3 times per day for 24 days using cellular telephones.
- Participants receive compensation for office visits, study telephone calls, cellular telephone reports, and follow-up interviews.
- All participants will receive nicotine patches and one-on-one counseling (delivered over the phone and in person).
Some participants will be eligible for a second phase of treatment after a 4-week follow-up interview.
- One-half of people eligible for this phase of the study will be randomly assigned to receive a supply of non-nicotine cigarettes to smoke for up to 6 weeks. The non-nicotine cigarettes are designed to help break the habit of smoking and to help smokers return to being smoke-free after smoking regular cigarettes.
- The other one-half of eligible smokers will be randomly assigned to not receive these non-nicotine cigarettes.
- All smokers eligible for this phase of the study will be asked to complete cellular telephone reports about their mood, thoughts, and behaviors for 14 days beginning 4.5 weeks after a target stop-smoking date. Compensation will be provided for completing these cellular telephone phone reports.
研究类型
介入性
注册 (实际的)
93
阶段
- 不适用
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
-
-
New Jersey
-
New Brunswick、New Jersey、美国、08901
- Rutgers University Institute for Health, Health Care Policy, and Aging Research
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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
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 18 years of age or older
- Smoke cigarettes daily
- Motivated to quit smoking
- Able to read and write English
- Willing and able to complete study visits and cell phone calls
Exclusion Criteria:
- Pregnancy, breastfeeding, planning on becoming pregnant during the study
- Recent heart attack or heart surgery, heart disease, unstable angina
- Allergy to adhesives
- Past negative reactions to nicotine patch
- Serious skin conditions
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：Standard treatment
In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
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Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking
其他名称：
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实验性的：Standard treatment+practice quitting
In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
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This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
其他名称：
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实验性的：Very low nicotine cigarettes
In this condition, smokers from both the Standard treatment and the Standard treatment+practice quitting arms who have smoked in the last 7-days at a 4-week post-target-smoking-cessation-date follow-up interview may be randomly assigned to this group.
Those assigned to this group will receive a 6-week supply of cigarettes that contain tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine.
This treatment is designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking
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This intervention will be offered to a subset of smokers from both of the other study arms.
To be eligible for this intervention, participants must be smoking at the follow-up interview conducted four weeks after a target quit day in the two arms listed above.
Tobacco cigarettes containing very low levels of nicotine (.016-.019
mg in smoke from the cigarettes).
These are to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks.
|
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无干预：Advice and encouragement only
In this condition, smokers from both the Standard treatment and the Standard treatment+practice quitting arms who have smoked in the last 7-days at a 4-week post-target-smoking-cessation-date follow-up interview may be randomly assigned to this condition.
Those in this arm will receive advice and encouragement to try to stop smoking again after they have slipped (returned to smoking) during a stop smoking attempt.
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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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4-week Abstinence
大体时间：4 weeks
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7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt).
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4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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10-week Abstinence
大体时间：10 weeks
|
This captures whether any tobacco use occurred in the past 7 days at the 10-week follow up (i.e., whether any tobacco use occurred in the 10th week of the quit attempt), as reported by participants in a timeline follow-back telephone interview and confirmed by a follow-up expired carbon monoxide reading less than or equal to 8 parts per million.
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10 weeks
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Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date
大体时间：3 weeks pre-quit
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Emotional, mental, and behavioral measures that may help explain treatment effects on tobacco use outcomes will be assessed intensively in the three weeks leading up to a quit attempt and the first week of a quit attempt to examine mediators (confidence in quitting) of the first phase treatment.
These repeated measures will be analyzed to see if treatment affects them and if they predict smoking behavior.
Confidence related to quitting to for good was rated on a 5-point scale where 1=definitely not confident and 5=definitely confident.
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3 weeks pre-quit
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Prolonged Abstinence
大体时间：10 weeks
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This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt.
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10 weeks
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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：Danielle E McCarthy, Ph.D.、Rutgers University
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
2012年6月1日
初级完成 (实际的)
2013年7月1日
研究完成 (实际的)
2013年8月1日
研究注册日期
首次提交
2011年6月6日
首先提交符合 QC 标准的
2011年6月6日
首次发布 (估计)
2011年6月8日
研究记录更新
最后更新发布 (实际的)
2022年4月27日
上次提交的符合 QC 标准的更新
2022年3月30日
最后验证
2022年3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.