Nicotine Patch and Bupropion to Reduce Smoking Rates in Younger, Low-Income, and Minority Individuals
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Nicotine Patch; Sustained Release Bupropion
Intervention type(s): Drug; Drug
Intervention description(s): After determining that it is appropriate to dispense study medication to a participant, the dosing regimen will be determined. Participants who report smoking more than 20 cigarettes each day will be initially placed on the 21 mg patch; participants who report smoking 10 - 19 cigarettes each day will be initially placed on the 14 mg patch; participants who report smoking 5 - 9 cigarettes will be initially placed on the 7 mg patch.
If a participant is initially placed on the 21 mg patch, the following dosing schedule will occur: 21 mg patch for 4 weeks, 14 mg patch for 4 weeks, 7 mg patch for 2 weeks, and then off. If a participant is initially placed on the 14 mg patch, the following dosing schedule will occur: 14 mg patch for 6 weeks, 7 mg patch for 4 weeks, and then off. If a participant is initially placed on the 7 mg patch, the following dosing schedule will occur: 7 mg patch for 10 weeks, and then off.; Participants will receive the sustained-release bupropion 150 mg tablet in the morning for four days. If this dose is well-tolerated, then the dose will be increased to a 150 mg tablet twice daily, with at least 8 hours between the two doses. The sustained-release bupropion medication will begin at the randomization visit (RV) which is approximately one week before the quit date. At the RV, the participant should be dispensed enough of the 150 mg tablets of the sustained-release bupropion or placebo to return for the first follow-up visit with instructions on use. Participants will be evaluated by telephone on their quit date approximately one week after the RV to assess safety. We will discontinue the sustained-release bupropion at the second follow-up visit, at which time participants will have received sustained-release bupropion for approximately 11 weeks.
Intervention MeSH terms: Bupropion; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking Cessation; Nicotine Dependence