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临床试验/NCT01120080
NCT01120080已完成1 期

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

Yale University2 个研究点 分布在 1 个国家目标入组 1,948 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
1,948
试验地点
2
主要终点
Efficacy of advice to limit or abstain from alcohol use in improving smoking cessation.

研究概览

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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