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Smoking Cessation for Young Adults Who Binge Drink - 1

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ClinicalTrials.gov Identifier: NCT00218452
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 7, 2015
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Steven Ames, Mayo Clinic

September 16, 2005
September 22, 2005
April 7, 2015
September 2005
December 2007   (Final data collection date for primary outcome measure)
Treatment attendance [ Time Frame: week 12 and week 24 ]
quantified as the percentage of sessions attended, will be summarized separately for each treatment group and compared between groups using the rank sum test. One summary will be performed for the percentage of sessions attended face-to-face and a second summary will be performed for the percentage of sessions attended either face-to-face or via telephone.
Treatment compliance
Complete list of historical versions of study NCT00218452 on ClinicalTrials.gov Archive Site
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Smoking Cessation for Young Adults Who Binge Drink - 1
Smoking Cessation for Young Adults Who Binge Drink
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.
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.
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Adherence
  • Tobacco Use Cessation
  • Alcohol & Drug Use
  • Nicotine Transdermal System
Behavioral: Lifestyle counseling
assigned to a 6-week individual behavioral treatment involving: 1) a novel brief office intervention for cigarette smoking that includes a treatment component intended to eliminate binge drinking
Experimental: Lifestyle counseling
Intervention: Behavioral: Lifestyle counseling
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2008
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

(1) Aged 18-25 years. (2) Enrolled as a 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.

Sexes Eligible for Study: All
18 Years to 25 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R21DA018106 ( U.S. NIH Grant/Contract )
NIDA-18106-1 ( Other Identifier: NIDA )
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Steven Ames, Mayo Clinic
Mayo Clinic
National Institute on Drug Abuse (NIDA)
Principal Investigator: Steven C Ames, Ph.D. Mayo Clinic
Mayo Clinic
April 2015

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