Maintaining Nonsmoking: Older Smokers - 1
2015年3月3日 更新者：University of California, San Francisco
Maintaining Nonsmoking: Older Smokers
The purpose of this study was to examine pharmacological and psychological interventions for smokers over 50.
研究概览
详细说明
The overall goals of this line of research were to prevent relapse to cigarette smoking, and to understand the processes related to smoking and relapse.
The specific aims of the current study were to test a series of hypotheses about the efficacy and cost-effectiveness of long-term, tailored interventions in chronic, older smokers and the interaction of these interventions with gender and depression.
Participants were 50 years or older and smoker 10 or more cigarettes per day.
Baseline assessments includes measures of smoking behavior, nicotine dependence, depression diagnosis, demographics and life circumstances and measures of anger, depression and mood disturbance, stress, social support, health status, motivation for changed and drug and alcohol use.
研究类型
介入性
注册 (实际的)
403
阶段
- 第三阶段
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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California
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San Francisco、California、美国、94143
- San Francisco
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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
50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
smokers of at least 10 cigarettes per day
Inclusion Criteria:
MULTIPLE
Exclusion Criteria:
MULTIPLE
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：Brief Treatment
Pharmacological Treatment - Subjects received 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment (NRT) Brief Counseling - The counseling intervention consisted of five 90-minute group meetings. There was no further treatment during Weeks 12-52. |
Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
其他名称：
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实验性的：Extended NRT
Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition would continue receiving NRT for up to 52 weeks. Subjects in this condition would be encouraged to continue NRT through Week 24. If a subject terminated NRT and resumed smoking, before Week 50, would be instructed to set a quit date and resume NRT. Counseling Treatment - This is identical to the Brief Counseling described above. |
Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
其他名称：
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实验性的：Tailored/No Extended NRT
This condition was identical to the Tailored/NRT condition except that no NRT was available after completion of the Brief Treatment.
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Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
其他名称：
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实验性的：Extended Tailored Counseling + NRT
Tailored Counseling Treatment- The primary goal of the extended treatment was to prevent relapse.
Secondary goal was to encourage initiation of abstinence for those who have not attained it by Week 12, and re-initiation of abstinence after slips.
Subjects would participate in the Brief Treatment followed by individual sessions.
The first extended treatment counseling session would occur at Week 10.
Additional sessions would be held every two weeks then every four weeks, and finally at Weeks 44 and 52.
Each session would be 20-30 minutes long.
Between sessions subjects would be contacted by phone for brief check-ins (5-10 minutes).
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Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
其他名称：
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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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Participants Abstinent From Cigarettes
大体时间：Two years
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Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104
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Two years
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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：Sharon M Hall, Ph.D.、University of California, San Francisco
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。
一般刊物
- Barnett PG, Wong W, Jeffers A, Munoz R, Humfleet G, Hall S. Cost-effectiveness of extended cessation treatment for older smokers. Addiction. 2014 Feb;109(2):314-22. doi: 10.1111/add.12404. Epub 2013 Dec 13.
- Hall SM, Humfleet GL, Munoz RF, Reus VI, Robbins JA, Prochaska JJ. Extended treatment of older cigarette smokers. Addiction. 2009 Jun;104(6):1043-52. doi: 10.1111/j.1360-0443.2009.02548.x. Epub 2009 Apr 9. Erratum In: Addiction. 2011 Jun;106(6):1204.
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
2001年9月1日
初级完成 (实际的)
2009年3月1日
研究完成 (实际的)
2009年3月1日
研究注册日期
首次提交
2004年7月1日
首先提交符合 QC 标准的
2004年7月6日
首次发布 (估计)
2004年7月7日
研究记录更新
最后更新发布 (估计)
2015年3月23日
上次提交的符合 QC 标准的更新
2015年3月3日
最后验证
2015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.