Alcohol Counseling for Telephone Quitline Callers

Yale University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Nicotine Dependence; Smoking; Alcohol Dependence

Treatments: Behavioral: Practical Counseling; Behavioral: Alcohol Intervention Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01120080

091105931 (Other Identifier)

R01CA140256 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,948 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Eligible for Enhanced Services Program

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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1,948 participants in 2 patient groups, including a placebo group

Practical Counseling

Placebo Comparator group

Treatment:

Behavioral: Practical Counseling

Alcohol Intervention Counseling

Active Comparator group

Treatment:

Behavioral: Alcohol Intervention Counseling