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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Mayo Clinic |
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00218452 |
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 |
Behavioral: Tobacco Use Cessation |
MedlinePlus related topics: | Quitting Smoking Smoking |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Smoking Cessation for Young Adults Who Binge Drink |
Estimated Enrollment: | 74 |
Study Start Date: | September 2005 |
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 to 25 Years |
Genders Eligible for Study: | Both |
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.
Contact: Edgar Covil | (904)953-7850 |
United States, Florida | |||||
Mayo Clinic Jacksonville | Recruiting | ||||
Jacksonville, Florida, United States, 32224 | |||||
Contact: Steven C Ames, Ph.D. 904-953-6822 ames.steven@mayo.edu | |||||
University of North Florida | Recruiting | ||||
Jacksonville, Florida, United States, 32224 | |||||
Contact: Gretchen E Ames, Ph.D. 904-620-2807 | |||||
United States, Minnesota | |||||
Mayo Clinic Rochester | Not yet recruiting | ||||
Rochester, Minnesota, United States, 55905 | |||||
Contact: Christi Patten, Ph.D. 507-538-7370 patten.christi@mayo.edu |
National Institute on Drug Abuse (NIDA) |
Mayo Clinic |
Principal Investigator: | Steven C Ames, Ph.D. | Mayo Clinic |
Study ID Numbers: | NIDA-18106-1, R21-18106-1 |
First Received: | September 16, 2005 |
Last Updated: | February 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00218452 |
Health Authority: | United States: Federal Government; Mayo Foundation: IRB |
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