跳至主要内容
临床试验/NCT01120080
NCT01120080
已完成
1 期

Advancing Tobacco and Cancer Control: Reducing Alcohol Use to Promote Smoking Cessation

Yale University1 个研究点 分布在 1 个国家目标入组 1,948 人2011年1月

概览

阶段
1 期
干预措施
未指定
疾病 / 适应症
Smoking
发起方
Yale University
入组人数
1948
试验地点
1
主要终点
Efficacy of advice to limit or abstain from alcohol use in improving smoking cessation.
状态
已完成
最后更新
6年前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2011年1月
结束日期
2012年5月
最后更新
6年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Adults (18+ years)
  • Cigarette smokers requesting assistance with quitting smoking
  • Hazardous drinkers (per NIAAA criteria)

排除标准

  • Eligible for Enhanced Services Program

结局指标

主要结局

Efficacy of advice to limit or abstain from alcohol use in improving smoking cessation.

时间窗: 6 Months

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.

次要结局

  • Does reductions in alcohol use mediate smoking cessation success(6 Months)
  • What factors that determine smoking cessation success also determine who is more likely to respond to the alcohol intervention(6 Months)
  • Efficacy of advice to limit or abstain from alcohol use.(6 Months)

研究点 (1)

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