We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Smoking Cessation for Young Adults Who Binge Drink - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00218452
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 7, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Adherence Tobacco Use Cessation Alcohol & Drug Use Nicotine Transdermal System Behavioral: Lifestyle counseling Early Phase 1

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smoking Cessation for Young Adults Who Binge Drink
Study Start Date : September 2005
Primary Completion Date : December 2007
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lifestyle counseling 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

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218452

United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
University of North Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute on Drug Abuse (NIDA)
Principal Investigator: Steven C Ames, Ph.D. Mayo Clinic
More Information

Responsible Party: Steven Ames, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00218452     History of Changes
Other Study ID Numbers: 1996-04
R21DA018106 ( U.S. NIH Grant/Contract )
NIDA-18106-1 ( Other Identifier: NIDA )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Steven Ames, Mayo Clinic:
Tobacco use cessation