Targeted Intervention for Bipolar Smokers
2014年1月3日 更新者:University of Cincinnati
The purpose of this research is to develop and test a new type of smoking cessation counseling for individuals with bipolar disorder.
研究概览
详细说明
All participants will receive the nicotine patch, an FDA-approved smoking cessation medication, in an open-label fashion.
In addition to the nicotine patch, participants will be randomized to receive one of the two types of counseling for smoking cessation.
Participants will be in the research study for approximately 18 weeks.
The total number of study visits is 15.
研究类型
介入性
注册 (预期的)
50
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
-
-
Ohio
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Cincinnati、Ohio、美国、452219
- The University of Cincinnati
-
-
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:
- Participants who are motivated to quit smoking
- Male or female
- 18 years of age or older
- Diagnosed with bipolar disorder according to DSM-IV criteria
- Stable on medication with no significant changes in the last 3 months before enrollment.
- Smoking 10 cigarettes/day for the past 90 days
Exclusion Criteria:
- Healthy volunteers
- Patients not meeting the criteria for the diagnosis of Bipolar Disorder according to DSM-IV criteria
- Not being and being treated with medication for the bipolar disorder
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 |
---|---|
实验性的:Counseling/Mood Management
A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting and to help you develop knowledge and skills that can help you quit.
Also, subjects will receive the National Cancer Institute's "Clearing the Air" guide to smoking cessation.
Some specific areas of focus for this intervention are managing negative moods without smoking and overcoming other obstacles to quitting.
|
A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting smoking and to help develop knowledge and skills for quitting.
Also, subjects will receive the National Cancer Institute's "Clearing the Air" guide to smoking cessation.
Some specific areas of focus for this intervention are managing negative moods without smoking and overcoming other obstacles to quitting.
其他名称:
|
有源比较器:Counseling/Healthy Lifestyle
A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting smoking and to help develop knowledge and skills for quitting.
Also, subjects will receive the National Cancer Institute's "Clearing the Air" guide to smoking cessation.
Some specific areas of focus for this intervention are developing a better understanding of reasons for smoking and the consequences of tobacco use and identifying ways to establish a healthier lifestyle.
|
A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting and to help develop knowledge and skills for quitting.
Also, the National Cancer Institute's "Clearing the Air" guide to smoking cessation will be given to subjects.
Some specific areas of focus for this intervention are developing a better understanding of reasons for smoking and the consequences of tobacco use and identifying ways for establishing a healthier lifestyle.
其他名称:
|
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 |
---|---|---|
Prolonged Abstinence from Smoking
大体时间:Last four weeks of treatment period
|
Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period.
|
Last four weeks of treatment period
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Prevalence of Abstinence from Smoking
大体时间:Last 7 days of treatment period
|
Prevalence abstinence will be assessed during the last 7 days of treatment period, 7 days prior to follow-up visit.
|
Last 7 days of treatment period
|
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:Jaimee Heffner, MD、University of Cincinnati
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
2010年7月1日
初级完成 (预期的)
2014年8月1日
研究完成 (预期的)
2014年8月1日
研究注册日期
首次提交
2011年4月21日
首先提交符合 QC 标准的
2012年3月8日
首次发布 (估计)
2012年3月9日
研究记录更新
最后更新发布 (估计)
2014年1月7日
上次提交的符合 QC 标准的更新
2014年1月3日
最后验证
2014年1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.
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