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

This study has been completed.
Sponsor:
Collaborator:
James and Esther King Biomedical Research Program
Information provided by (Responsible Party):
Steven Ames, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01184261
First received: August 17, 2010
Last updated: March 24, 2014
Last verified: March 2014

August 17, 2010
March 24, 2014
August 2010
February 2013   (final data collection date for primary outcome measure)
Biochemically-confirmed 7-day point prevalence tobacco abstinence [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
Tobacco Abstinence [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01184261 on ClinicalTrials.gov Archive Site
  • Effect of the integrated intervention on binge drinking [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
  • Possible mediators of the intervention [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
Alcohol Consumption [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
for Cigarette Smoking and Binge Drinking Cessation
Behavioral: behavioral intervention
8 session behavioral intervention.
Other Names:
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Experimental: Arm I
    Patients attend behavioral sessions for smoking and binge drinking cessation over 30 minutes once weekly in weeks 1-6.
    Intervention: Behavioral: behavioral intervention
  • Experimental: Arm II
    Patients attend behavioral sessions for smoking cessation over 30 minutes once weekly in weeks 1-6.
    Intervention: Behavioral: behavioral intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
February 2013
February 2013   (final data collection date for primary outcome measure)

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

Both
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01184261
10-000432, NCI-2010-01881
Yes
Steven Ames, Mayo Clinic
Mayo Clinic
James and Esther King Biomedical Research Program
Principal Investigator: Steven Ames Mayo Clinic
Mayo Clinic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP