A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users
2017年8月17日 更新者：Johns Hopkins University
Cigarette smoking is very common in current and former injection drug users and is known to cause chronic lung diseases.
Quitting smoking is proven to improve the health of people addicted to cigarettes. .
Little information exists regarding the perceptions and characteristics of drug users regarding quitting smoking.
Additionally, most programs designed to help people quit smoking are not very successful.
One reason these programs may not work well is because it is difficult to motivate people to quit smoking.
New methods of motivating changes in behavior include small monetary payments for healthy behavior and reporting breathing tests with the concept of "lung age," which is the age of an average healthy person with similar breathing test results.
For example, a health care provider can report results as "Although you are 50 years old, you have the lungs for a 70 year old".
In this proposal, the investigators plan to first explore the beliefs and characteristics of current and former injection drug users and how they are related to quitting smoking.
The investigators then plan to study whether the use of two new methods of motivation increases the chances that this group will stop smoking.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
100
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
-
-
Maryland
-
Baltimore、Maryland、美国、21287
- Johns Hopkins ALIVE Clinic
-
-
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:
- Active smoker
Exclusion Criteria:
- Enrollment in smoking cessation protocol
- Current use of nicotine replacement therapy
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：预防
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：日常护理
|
After participants have completed the data collection portion of the SHIELD visit, the research assistant will provide the participant with an informational flyer regarding the risks of tobacco smoking and benefits of tobacco cessation.
The participant will be provided the phone number for the Tobacco Quit Line in Maryland as well as a list of local tobacco cessation programs.
Any questions will be answered by the research assistant.
If the participant inquires about nicotine replacement therapy, they will be advised to contact their primary care provider to discuss potential therapeutic options.
Spirometry results will be verbally disclosed to participants describing their lung function as a percent of predicted value.
A handout with these results will be given to participants.
At each follow-up visit, after obtaining CO and questionnaire data, spirometry results will be reviewed and participants will be offered the informational flyer and quit line number.
|
|
有源比较器：Lung Age
|
For individuals randomized to spirometric lung age intervention, after completion of data collection, CO level and acceptable spirometry, the participant will be verbally informed of spirometric results.
It will be explained that lung function normally reduces with age and that smoking can damage lung as if they were aging more rapidly than normal using visual depictions.
Their lung function estimates based on their chronological age and lung age will be provided.
They will be informed that smoking cessation would slow the aging of their lungs.
After questions are answered, the participant will receive a written report that includes enumeration of their lung age and chronological age.
At initial and follow-up visits, the research assistant will provide the participant with the same informational flyer and Tobacco Quit Line in Maryland as the usual care intervention.
|
|
有源比较器：Contingency Management
|
For individuals randomized to CM, after completion of data collection, it will be explained to the participant that they will receive monetary compensation for biological confirmation of tobacco cessation.
At each visit, exhaled carbon monoxide levels will be checked.
If the subject has a negative CO level, they will be compensated.
If a participant has a CO consistent with recent tobacco use, (s)he will receive the payment for attending the visit, but no additional payment at that visit.
Spirometry results will be verbally disclosed to participants describing their lung function as a percent of predicted value.
A handout with these results will be given to participants.
At each follow-up visit, after obtaining CO and questionnaire data, spirometry results will be reviewed and participants will be offered the informational flyer and quit line number.
|
|
有源比较器：Lung age + Contingency Management
|
For individuals randomized to the combined contingency management + spirometric lung age intervention, after completion of data collection, CO level and acceptable spirometry, the participant will be described the process of contingency management as outlined above.
Following this, the research assistant will then describe lung age to the participant as described above.
At the end of this process, the participant will then receive the informational flyer, quit line and local tobacco cessation program information similar to the usual care intervention.
At each follow-up visit, after obtaining CO level and questionnaire outcomes, appropriate CM payment, review of participant's baseline lung age and informational flyer will occur.
|
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 confirmed tobacco cessation
大体时间：6 months
|
The primary outcome will be validated tobacco cessation at 6 months.
Biologically confirmed tobacco cessation will be assessed by self-report of smoking status combined with CO measurement.
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Self efficacy and intention to quit
大体时间：6 months
|
Self-efficacy and intention to quit smoking will be assessed at baseline using a modified version of the Prochaska stages of change questionnaire.
Quit attempts will be enumerated at follow-up visits by asking participants how many quit attempts they made in the prior six months.
|
6 months
|
|
Cessation attempts
大体时间：6 months
|
Cessation attempts will be quantified as the number of sustained cessation attempts lasting more than 7 days, number of sustained cessation attempts lasting more than one month and number of daily cigarettes smoked.
|
6 months
|
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。
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)
2011年4月1日
初级完成 (实际的)
2012年7月1日
研究完成 (实际的)
2012年7月1日
研究注册日期
首次提交
2011年4月12日
首先提交符合 QC 标准的
2011年4月12日
首次发布 (估计)
2011年4月13日
研究记录更新
最后更新发布 (实际的)
2017年8月22日
上次提交的符合 QC 标准的更新
2017年8月17日
最后验证
2017年8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.