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
  Purpose

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.


Condition Intervention
for Cigarette Smoking and Binge Drinking Cessation
Behavioral: behavioral intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Intervention for Cigarette Smoking and Binge Drinking for Young Adults

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Biochemically-confirmed 7-day point prevalence tobacco abstinence [ Time Frame: At week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 170
Study Start Date: August 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184261

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States
Sponsors and Collaborators
Mayo Clinic
James and Esther King Biomedical Research Program
Investigators
Principal Investigator: Steven Ames Mayo Clinic
  More Information

No publications provided

Responsible Party: Steven Ames, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01184261     History of Changes
Other Study ID Numbers: 10-000432, NCI-2010-01881
Study First Received: August 17, 2010
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Smoking
Binge-Eating Disorder
Habits
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014