Alcohol Counseling for Telephone Quitline Callers

Phase 1

Completed

• Conditions: Smoking; Alcohol Dependence; Nicotine Dependence
• Interventions: Behavioral: Alcohol Intervention Counseling; Behavioral: Practical Counseling

• Registration Number: NCT01120080
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-10
• Study Start: 2011-01
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-01
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1948

Inclusion Criteria

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

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Exclusion Criteria

• Eligible for Enhanced Services Program

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alcohol Intervention Counseling	Alcohol Intervention Counseling	-
Practical Counseling	Practical Counseling	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States