Alcohol Counseling for Telephone Quitline Callers

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120080
• Other study ID #: 091105931
• Secondary ID: 091105931R01CA14
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: January 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1948
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (18+ years)

• Cigarette smokers requesting assistance with quitting smoking

• Hazardous drinkers (per NIAAA criteria)

Exclusion Criteria:

• Eligible for Enhanced Services Program

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Nicotine Dependence
• Smoking
• Tobacco Use Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of advice to limit or abstain from alcohol use in improving smoking cessation.	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.	6 Months
Secondary	Efficacy of advice to limit or abstain from alcohol use.	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.	6 Months
Secondary	Does reductions in alcohol use mediate smoking cessation success	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.	6 Months
Secondary	What factors that determine smoking cessation success also determine who is more likely to respond to the alcohol intervention	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	6 Months