Alcohol Counseling for Telephone Quitline Callers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Benjamin A. Toll, Yale University
ClinicalTrials.gov Identifier:
NCT01120080
First received: April 26, 2010
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 Yale University:

Primary Outcome Measures:
  • Efficacy of advice to limit or abstain from alcohol use in improving smoking cessation. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120080

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

No publications provided

Responsible Party: Benjamin A. Toll, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01120080     History of Changes
Other Study ID Numbers: NCI R01 CA140256-01A1, 091105931, R01CA140256
Study First Received: April 26, 2010
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Smoking
Tobacco
Drinking

Additional relevant MeSH terms:
Alcoholism
Tobacco Use Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014