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Alcohol Counseling for Telephone Quitline Callers

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Benjamin A. Toll, Yale University Identifier:
First received: April 26, 2010
Last updated: January 18, 2013
Last verified: January 2013
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.

Condition Intervention Phase
Nicotine Dependence
Alcohol Dependence
Behavioral: Practical Counseling
Behavioral: Alcohol Intervention Counseling
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Advancing Tobacco and Cancer Control: Reducing Alcohol Use to Promote Smoking Cessation

Resource links provided by NLM:

Further study details as provided by Benjamin A. Toll, Yale University:

Primary Outcome Measures:
  • Efficacy of advice to limit or abstain from alcohol use in improving smoking cessation. [ Time Frame: 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:
  • Efficacy of advice to limit or abstain from alcohol use. [ Time Frame: 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.

  • Does reductions in alcohol use mediate smoking cessation success [ Time Frame: 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 [ Time Frame: 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

Enrollment: 1948
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Practical Counseling Behavioral: Practical Counseling
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.
Active Comparator: Alcohol Intervention Counseling Behavioral: Alcohol Intervention Counseling
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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Eligible for Enhanced Services Program
  Contacts and Locations
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Please refer to this study by its identifier: NCT01120080

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Yale University
National Cancer Institute (NCI)
Principal Investigator: Benjamin A. Toll, Ph.D. Yale University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Benjamin A. Toll, Associate Professor of Psychiatry, Yale University Identifier: NCT01120080     History of Changes
Other Study ID Numbers: NCI R01 CA140256-01A1
091105931 ( Other Identifier: Yale Univ. School of Medicine Human Investigation Committee )
R01CA140256 ( US NIH Grant/Contract Award Number )
Study First Received: April 26, 2010
Last Updated: January 18, 2013

Keywords provided by Benjamin A. Toll, Yale University:

Additional relevant MeSH terms:
Tobacco Use Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on May 25, 2017