Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers
Condition: Smoking; Pulmonary Disease, Chronic Obstructive; Tobacco Use Disorder
MeSH terms: Pulmonary Disease, Chronic Obstructive; Tobacco Use Disorder
Intervention: Standard Smoking Cessation; Extended Nicotine Replacement Therapy; Nicotine replacement therapy
Intervention description: Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.; Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 398.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: smoking cessation; tobacco use cessation products; nicotine

Summary:

      Long-term NRT has not been studied in patients with COPD, and smokers in the United States
      with COPD are still asked to choose between immediate quitting or continued smoking. The
      purpose of this study is to see if guided maintenance therapy (GMT), using long-term NRT,
      might prove to be a reasonable alternative to the standard approach of asking patients to
      quit immediately. The investigators believe that GMT with long-term NRT will reduce overall
      exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater
      quit rates.

      In this study, 398 smokers with COPD will be randomly assigned to either receive: 1)
      traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT
      (GMT). The SC intervention will be based on a standard approach to smoking cessation,
      including smoking cessation counseling supplemented with combination NRT (a nicotine patch
      plus the patient's choice of gum or lozenge) if they are willing to make a quit attempt. The
      GMT intervention will consist of counseling, focused on medication adherence and smoking
      reduction, plus 52 weeks of combination NRT. After 3, 6 and 12 months of treatment, we will
      compare the two treatments based on their effects on smoking cessation, number of cigarettes
      smoked, exposure to carbon monoxide and smoking-related carcinogens, COPD symptoms, breathing
      function, and smoking-related hospitalizations or death. The investigators will also analyze
      the data in such a way that will be able to identify which patients are most likely to
      benefit from treatment. This analysis will allow patients to estimate their chances of
      success based on their own personal characteristics and which treatment they choose.

      The investigators study addresses research priorities identified in recent smoking cessation
      guidelines and builds upon the input of our Patient Advisory Panel and our Stakeholder
      Advisory Committee. This study reflects the interests expressed by smokers in prior surveys
      and addresses the limited reach and effectiveness of traditional approaches to smoking
      cessation. If our GMT approach is effective, our study could change the recommendations
      provided in clinical practice guidelines and change the way that insurance companies pay for
      smoking cessation treatment. GMT could provide an alternative for millions of smokers with
      COPD who are not currently benefiting from traditional approaches to smoking cessation
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Physician-diagnosed COPD

          -  Smoke 5 or more cigarettes/day

          -  Smoke cigarettes on 25 or more of the last 30 days

          -  Speak either English or Spanish

          -  Willing to take nicotine replacement therapy for up to 1 year and participate in study
             procedures

        Exclusion Criteria:

          -  Reside in a facility that does not allow smoking

          -  Don't have an address and telephone

          -  Unstable cardiac condition (e.g. unstable angina or myocardial infarction in the past
             30 days)

          -  Pregnant or breastfeeding

          -  Terminal illness with less than 12 month life expectancy