Clinical trial NCT01184261: Integrated Behavioral Intervention for Cigarette Smoking and Binge Drinking in Young Adults
Official title: Integrated Intervention for Cigarette Smoking and Binge Drinking for Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: for Cigarette Smoking and Binge Drinking Cessation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: James and Esther King Biomedical Research Program
First posted: 2010-08-18
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Biochemically-confirmed 7-day point prevalence tobacco abstinence
timeFrame: At week 24
Secondary outcomes:
measure: Effect of the integrated intervention on binge drinking
timeFrame: At week 24
measure: Possible mediators of the intervention
timeFrame: At week 24
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Steven Ames
role: PRINCIPAL_INVESTIGATOR
References: