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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Integrated Intervention for Cigarette Smoking and Binge Drinking for Young Adults

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Mayo Clinic

Current Primary Outcome: Biochemically-confirmed 7-day point prevalence tobacco abstinence [ Time Frame: At week 24 ]

Original Primary Outcome: Tobacco Abstinence [ Time Frame: 6 Months ]

Current Secondary Outcome:

  • Effect of the integrated intervention on binge drinking [ Time Frame: At week 24 ]
  • Possible mediators of the intervention [ Time Frame: At week 24 ]


Original Secondary Outcome: Alcohol Consumption [ Time Frame: 6 months ]

Information By: Mayo Clinic

Dates:
Date Received: August 17, 2010
Date Started: August 2010
Date Completion:
Last Updated: March 24, 2014
Last Verified: March 2014