The purpose of this study is develop and test the success of a new smoking cessation intervention that includes a component to eliminate binge drinking.

Condition	Intervention
Adherence Tobacco use cessation alcohol & drug use nicotine transdermal system	Behavior: Tobacco Use Cessation

Further Study Details: 

Primary Outcomes: Treatment compliance
Expected Total Enrollment:  74

The primary aim of this pilot investigation is to develop and evaluate the acceptability and feasibility of a novel tobacco dependence intervention that includes a component to eliminate binge drinking. This study will also estimate the magnitude of the effect of the novel intervention on the cigarette smoking behavior of young adult college student smokers.

Ages Eligible for Study:  18 Years   -   25 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

(1) Aged 18-25 years. (2) Enrolled as a full time student at a two or four year technical or non-technical college or university. (3) Smoked > 10 or more cigarettes per day during the past 6 months. (4) Binge drank on > 2 occasions per month during the past 3 months. Binge drinking is defined as consumption of > 5 standardized alcoholic drinks in a row for males or > 4 drinks in a row for females. (5) Able to participate fully in all aspects of the intervention and keep all scheduled appointments. (6) Willing to participate in 6 months of follow-up. (7) Willing to stop smoking and use nicotine patch therapy. (8) Willing to refrain from participating in additional smoking interventions for the duration of the study. (9) Provide written informed consent. (10) General good health as determined by screening physician or registered nurse.

Exclusion Criteria:

(1) Current (past 90 days) alcohol dependence as assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders, Alcohol Dependence Module. (2) Current (past 12 months) non-nicotine or alcohol drug dependence as assessed by a Drug Abuse Screening Test-20 score of > 6. (3) 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. (4) Current use (past 30 days) of nicotine containing medication or tobacco products other than cigarettes. (5) Current use (past 30 days) of any other smoking cessation treatment involving behavioral or pharmacological interventions. (6) 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.

(7) Currently pregnant or breast feeding, or likely to become pregnant during the nicotine patch phase.

Please refer to this study by ClinicalTrials.gov identifier  NCT00218452

Edgar Covil      (904)953-7850 

Florida
      Mayo Clinic Jacksonville, Jacksonville,  Florida,  32224,  United States
      University of North Florida, Jacksonville,  Florida,  32224,  United States
Minnesota
      Mayo Clinic Rochester, Rochester,  Minnesota,  55905,  United States

Study chairs or principal investigators

Steven C Ames, Ph.D.,  Principal Investigator,  Mayo Clinic Jacksonville   

Study ID Numbers:  NIDA-18106-1; R21-18106-1
Last Updated:  September 21, 2005
Record first received:  September 16, 2005
ClinicalTrials.gov Identifier:  NCT00218452
Health Authority: United States: Federal Government; Mayo Foundation: IRB
ClinicalTrials.gov processed this record on 2005-09-27