Pager-Assisted Smoking Cessation Treatment (Pager)
2017年10月29日 更新者：Timothy Carmody、University of California, San Francisco
The proposed study tests the efficacy of using pager-assisted messages combined with nicotine patches in facilitating smoking cessation and relapse prevention in a 2-arm randomized clinical trial.
The hypothesis is that the proportion of biochemically-verified quitters at 3 and 12 months in the study arm randomized to receive therapeutic messages on alphanumeric pagers for 3 months along with individual smoking cessation counseling and nicotine patches will be greater that the proportion of biochemically-verified quitters who receive only individual smoking cessation counseling and nicotine patches.
研究概览
详细说明
A total of 224 current smokers were enrolled in a randomized controlled smoking cessation trial.
Participants were community-living adult smokers of ≥10 cigarettes per day during the pre-enrollment week who were interested in quitting and recruited from the local area by means of print, media, and online advertisements.
To be eligible, they needed to be smoking 10 or more cigarettes per day, aged 18 or older, motivated to quit smoking, prepared to set a quit date, willing to use nicotine patches, and able to come to therapy sessions and be followed by telephone.
Participants in the pager treatment were provided with alpha-numeric pagers free of charge for three months.
Using specially-designed communication software, text messages were sent to participants aimed at facilitating motivation to quit, cessation strategies, and coping skills to maintain abstinence.
Participants in both treatment groups were seen for two 60-minute sessions of standard smoking cessation counseling, and received three follow-up phone calls and two months of nicotine patches.
研究类型
介入性
注册 (实际的)
224
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
-
-
California
-
San Francisco、California、美国、94121
- San Francisco Veterans Affairs Medical Center
-
-
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 至 80年 (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:
- smoking 10 or more cigarettes per day
- aged 18 or older
- motivated to quit smoking and prepared to set a quit date
- willing to use nicotine patches
- ability to come to therapy sessions and be followed by telephone
Exclusion Criteria:
- individuals who are psychotic
- severely depressed
- organically brain impaired
- actively abusing alcohol or other substances, and/or who have been drug dependent during the past six months
- terminally ill
- unable to be contacted by phone,currently using nicotine replacement or smoking cessation medications
- those with contraindications to nicotine patches, female smokers who are pregnant or breastfeeding
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：Pager Arm
Participants in the Pager Arm will be provided with alphanumeric pagers and will receive therapeutic messages on these pagers for 3 months in addition to individual smoking cessation counseling and nicotine patches.
|
two 60-minute face-to-face treatment sessions and three 20-minute follow-up contacts at weeks 2, 3, and 9
其他名称：
8 weeks' worth of nicotine patches
其他名称：
therapeutic messages to be delivered for three months
其他名称：
|
|
有源比较器：Control Arm
Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches.
|
two 60-minute face-to-face treatment sessions and three 20-minute follow-up contacts at weeks 2, 3, and 9
其他名称：
8 weeks' worth of nicotine patches
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 |
|---|---|---|
|
biologically-validated point prevalence smoking cessation
大体时间：12 months after enrollment
|
Abstinence from cigarettes "even a puff", other tobacco products and nicotine replacement for seven days at the 12 month follow-up date as validated by salivary cotinine less than 15 ng/ml
|
12 months after enrollment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
continuous abstinence from cigarettes "even a puff", tobacco products and nicotine replacement
大体时间：12 months after enrollment
|
maintained cessation from smoking, biologically-validated by repeated measures of salivary cotinine less than 15 ng/ml at 12 months
|
12 months after enrollment
|
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：Timothy P Carmody, Ph.D、University of California, San Francisco
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
2003年5月1日
初级完成 (实际的)
2005年12月1日
研究完成 (实际的)
2005年12月1日
研究注册日期
首次提交
2010年9月21日
首先提交符合 QC 标准的
2010年9月21日
首次发布 (估计)
2010年9月22日
研究记录更新
最后更新发布 (实际的)
2017年10月31日
上次提交的符合 QC 标准的更新
2017年10月29日
最后验证
2017年10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.