Integrated Behavioral Intervention for Cigarette Smoking and Binge Drinking in Young Adults

Integrated Intervention for Cigarette Smoking and Binge Drinking for Young Adults

RATIONALE: Nicotine patches and behavioral therapy may help reduce cigarette smoking and binge drinking in young adults. PURPOSE: This randomized clinical trial studies nicotine patches with or without behavioral therapy in reducing cigarette smoking and binge drinking in young adults.

Study Overview

• Status: Completed
• Conditions: for Cigarette Smoking and Binge Drinking Cessation
• Intervention / Treatment: Behavioral: behavioral intervention

Detailed Description

OBJECTIVES: I. To evaluate the efficacy of Integrated Intervention that targets both cigarette smoking and binge drinking on the cigarette smoking behavior of young adult smokers at 6-month follow-up. II. To evaluate the efficacy of Integrated Intervention that targets both cigarette smoking and binge drinking on binge drinking behavior of young adult smokers. III. Examine the effect of Integrated Intervention on several possible mediators of change corresponding to mechanisms that have been proposed to account for the relationship between cigarette smoking and alcohol use. These mediators include cravings to smoke, perceived similarity to the typical smoker, and self-efficacy for smoking abstinence. OUTLINE: Patients are randomized to 1 of 2 treatment arms.All patients receive nicotine patch therapy in weeks 4-11. ARM I: Patients attend behavioral sessions for smoking and binge drinking cessation over 30 minutes once weekly in weeks 1-6. ARM II: Patients attend behavioral sessions for smoking cessation over 30 minutes once weekly in weeks 1-6.After completion of study treatment, patients are followed up at weeks 12, 16, 20, and 24.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria: - Smoked an average of >= 10 or more cigarettes per day during the past 6 months - Binge drank on an average of >= 2 occasions per month during the past 3 months - Able to participate fully in all aspects of the intervention and keep all scheduled appointments - Willing to participate in 6 months of follow-up - Willing to stop smoking and use nicotine patch therapy - Willing to refrain from participating in additional smoking interventions for the duration of the study - Provide written informed consent Exclusion Criteria: - Current (past 90 days) alcohol dependence as assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders, Alcohol Dependence Module - Current (past 12 months) non-nicotine or alcohol drug dependence as assessed by a Drug Abuse Screening Test-20 score of >= 6 - Current elevation of depressive symptoms (past 2 weeks) that would be indicative of clinical depression as assessed by a Beck Depression Inventory-II score of >= 20 - Current use (past 30 days) of nicotine containing medication or frequent use (> 10 occasions per month) of tobacco products other than cigarettes - Current use (past 30 days) of any other smoking cessation treatment involving behavioral or pharmacological interventions - Any medical condition that would preclude use of the nicotine patch including current unstable angina, recent history (past 30 days) of myocardial infarction or stroke, history of severe skin allergies, or evidence of severe chronic dermatosis - Currently pregnant or breast feeding, or likely to become pregnant during the nicotine patch phase

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I; Patients attend behavioral sessions for smoking and binge drinking cessation over 30 minutes once weekly in weeks 1-6.	Behavioral: behavioral intervention; 8 session behavioral intervention.; Other Names: Behavior or Life Style Modifications; Behavior Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment
Experimental: Arm II; Patients attend behavioral sessions for smoking cessation over 30 minutes once weekly in weeks 1-6.	Behavioral: behavioral intervention; 8 session behavioral intervention.; Other Names: Behavior or Life Style Modifications; Behavior Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biochemically-confirmed 7-day point prevalence tobacco abstinence	At week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Effect of the integrated intervention on binge drinking	At week 24
Possible mediators of the intervention	At week 24

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: James and Esther King Biomedical Research Program
• Investigators: Principal Investigator: Steven Ames, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: August 17, 2010
• First Submitted That Met QC Criteria: August 17, 2010
• First Posted (Estimate): August 18, 2010

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 24, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Binge Drinking
• Other Study ID Numbers: 10-000432; NCI-2010-01881