Tobacco Use Disorder Clinical Trial
Official title:
Clinical Trial of Two Medications on Smoking Cessation
Nicotine addiction is a serious health problem in the United States; 46 million people smoke cigarettes, and 70% of those are trying to quit. The nicotine patch and bupropion, a medication used to reduce nicotine cravings, are two commonly used smoking cessation aids. Both have been shown to reduce smoking rates, however, the effectiveness of combining the two treatments has not been widely examined. This study will evaluate the effectiveness of the nicotine patch combined with bupropion at reducing smoking rates among younger, low-income, and minority individuals.
Cigarette smoking poses a serious but preventable health risk. The negative health effects
of smoking are well-known, but the prevalence of cigarette smoking remains high in the
United States, particularly among younger people, people of lower socioeconomic status, and
minority groups. Nicotine replacement therapy, commonly known as the nicotine patch, has
been proven to be an effective treatment for reducing nicotine use. The nicotine patch
provides a measured dose of nicotine through the skin. By gradually lowering nicotine doses
over a period of time, individuals experience fewer nicotine cravings; the ultimate goal is
to stop using nicotine. Bupropion, a medication commonly used to treat depression, is also
used as a smoking cessation tool. It helps to control nicotine cravings. The majority of
studies on the nicotine patch and bupropion have been performed on older, white,
middle-class individuals; more research is needed to confirm the benefit of these treatments
in younger, low-income, and minority populations. While both the nicotine patch and
bupropion appear to be individually effective as smoking cessation aids, little is known on
the possible effectiveness of combining the two treatments. Because of the high relapse
rates in low-income and minority individuals, the combination of the nicotine patch with
bupropion may be particularly effective at reducing relapse rates in these individuals. The
purpose of this study is to evaluate the effectiveness of the nicotine patch and bupropion
at reducing smoking rates in younger, low-income, and minority individuals.
This 1-year study will enroll younger, low-income, and minority individuals who smoke.
Participants will be randomly assigned to one of the following three groups: 1) nicotine
patch plus placebo sustained-release bupropion; 2) placebo nicotine patch plus
sustained-release bupropion; or 3) nicotine patch plus sustained-release bupropion. At study
entry, participants will complete standardized psychological questionnaires to assess
depression levels and will undergo a physical exam and blood testing. Study visits will take
place at Weeks 5 and 11, Month 6, and Year 1. At each visit, questionnaires will be
completed, and smoking cessation rates will be assessed by self-report and verified by
saliva and exhaled carbon monoxide testing. In addition, all participants will take part in
a standardized behavioral smoking cessation program.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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