Smoking Cessation Treatment for Head and Neck Cancer Patients
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.
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This is a pilot research study examining the use of varenicline (Chantix) and the nicotine patch. The study is designed to find out whether one of these medications is more effective for smoking cessation with head and neck cancer patients. The study has three parts: 1) two intake sessions; 2) an 8-week treatment phase, and 3) a 3-month follow-up.
To develop an effect size estimate for smoking cessation defined as continuous abstinence over the last 4 weeks of treatment for 2 mg varenicline compared to nicotine patch. [ Time Frame: Eight weeks ]
Secondary Outcome Measures :
To examine tolerability of 2 mg varenicline and the 21 mg nicotine patch in smokers who have been diagnosed with head and neck cancer. [ Time Frame: Eight weeks ]
To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation. [ Time Frame: Eight weeks ]
To examine the effect of varenicline and nicotine patch on alcohol consumption. [ Time Frame: Eight weeks ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
age 18 or older
smoking 10 or more cigarettes per day
diagnosed with and completed an initial course of treatment for any type of head and neck cancer
life expectancy of 12 months or more
history of allergic reactions to adhesives
unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
females of childbearing potential who are pregnant, nursing, or not practicing effective contraception