Integrated Intervention for Cigarette Smoking and Binge Drinking for Young Adults
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| City: |
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Jacksonville |
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Florida |
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| Conditions: |
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for Cigarette Smoking and Binge Drinking Cessation |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01184261 |
| Primary Contact: |
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Principal Investigator
Steven Ames
Mayo Clinic
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| Backup Contact: |
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N/A |
| Location Contact: |
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Jacksonville, Florida
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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