Alcohol Counseling for Telephone Quitline Callers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01120080|
Recruitment Status : Completed
First Posted : May 10, 2010
Last Update Posted : January 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Smoking Nicotine Dependence Alcohol Dependence||Behavioral: Practical Counseling Behavioral: Alcohol Intervention Counseling||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1948 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Advancing Tobacco and Cancer Control: Reducing Alcohol Use to Promote Smoking Cessation|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
|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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120080
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Benjamin A. Toll, Ph.D.||Yale University|