Alcohol Counseling for Telephone Quitline Callers
2020年3月31日 更新者:Yale University
Advancing Tobacco and Cancer Control: Reducing Alcohol Use to Promote Smoking Cessation
The goal of this study is to train phone counselors working for the New York (NY) State Smokers' Quitline to advise callers who drink at hazardous levels to limit or abstain from alcohol use to determine whether this improves smoking cessation outcomes so that we can establish effect size estimates for a full scale multi-site trial.
研究概览
详细说明
This is a developmental study to: 1) create and beta test an alcohol counseling protocol with 25 Quitline callers and 2) train Quitline Specialists to provide an alcohol intervention using at least 100 pilot Quitline callers to ensure that Specialists in the alcohol intervention + standard care condition provide counseling that addresses hazardous drinking with a high level of alcohol intervention strategies and skill.
After this phase of the study is complete, a developmental randomized clinical trial will be conducted with 1,948 NY Quitline callers who drink at hazardous levels to compare practical counseling + smoking cessation print materials added to standard care (PC + SC condition) to alcohol intervention counseling + alcohol-focused print materials added to standard care (AI + SC condition).
Efficacy data from this trial will be used to determine effect size estimates for both quitdate and 7-month self-reported point prevalence abstinence rates.
Reduction in alcohol consumption and reduced drinking as a mediator of smoking cessation outcome will be secondary outcomes.
Other mediators and moderators of alcohol intervention effects will also be examined as an exploratory outcome.
If the effect size estimates are sufficiently large and medically important to pursue a definitive trial, these data will be used to propose a full scale multi-site large study.
If an alcohol intervention is shown to enhance treatment outcome in a large-scale study, alcohol interventions with quitline counselors could be translated for use by the entire NY state quitline and other quitlines across the country.
This may increase the effectiveness of quitline interventions and thus has the potential to reach millions of smokers, thereby bolstering tobacco and cancer control efforts across the United States.
研究类型
介入性
注册 (实际的)
1948
阶段
- 阶段2
- 阶段1
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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New York
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Buffalo、New York、美国、14263
- Roswell Park Cancer Institute
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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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adults (18+ years)
- Cigarette smokers requesting assistance with quitting smoking
- Hazardous drinkers (per NIAAA criteria)
Exclusion Criteria:
- Eligible for Enhanced Services Program
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:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较:Practical Counseling
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To ensure that treatment effects are not due to the longer counseling intervention and additional alcohol intervention workbook in the Alcohol Intervention plus Standard Care condition, we will provide additional smoking cessation advice that will not be specific to alcohol use and an additional smoking cessation workbook for participants in the Practical Counseling plus Standard Care condition.
Consistent with the Clinical Practice Guideline Update, we will include 5 minutes of practical counseling, which has been shown empirically to be effective in improving rates of smoking cessation.
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有源比较器:Alcohol Intervention Counseling
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The Alcohol Intervention counseling protocol will be adapted from Dr. Ockene's brief alcohol intervention protocol and Dr. Kahler's brief alcohol intervention for smokers: Feedback and discussion on the relationship between drinking and smoking, and on the potential effects of alcohol consumption on smoking cessation; an emphasis on personal Responsibility for choosing to change one's behavior; Advice to avoid or minimize drinking during the smoking cessation process; a Menu of options for carrying out a change strategy; use of Empathy by the clinician; and encouragement of Self-efficacy (i.e., confidence) for successful change.
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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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Efficacy of advice to limit or abstain from alcohol use in improving smoking cessation.
大体时间:6 Months
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To determine if advice to limit or abstain from alcohol use results in improved smoking cessation outcomes in 1,950 smokers who drink at hazardous levels and are calling a telephone Quitline.
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6 Months
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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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Efficacy of advice to limit or abstain from alcohol use.
大体时间:6 Months
|
To determine if advice to limit or abstain from alcohol use results in reduced alcohol consumption in 1,950 smokers who drink at hazardous levels and are calling a telephone Quitline.
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6 Months
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Does reductions in alcohol use mediate smoking cessation success
大体时间:6 Months
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To determine if reduction in alcohol use mediates smoking cessation success in 1,950 smokers who drink at hazardous levels and are calling a telephone Quitline.
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6 Months
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What factors that determine smoking cessation success also determine who is more likely to respond to the alcohol intervention
大体时间:6 Months
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To examine other mediators and moderators of smoking cessation effects to determine which factors and subgroups are more likely to respond to the alcohol intervention and discern mechanisms of treatment response
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6 Months
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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:Benjamin A. Toll, Ph.D.、Yale University
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
2011年1月1日
初级完成 (实际的)
2012年5月1日
研究完成 (实际的)
2012年5月1日
研究注册日期
首次提交
2010年4月26日
首先提交符合 QC 标准的
2010年5月6日
首次发布 (估计)
2010年5月10日
研究记录更新
最后更新发布 (实际的)
2020年4月2日
上次提交的符合 QC 标准的更新
2020年3月31日
最后验证
2013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.