Identifying Treatments to Motivate Smokers to Quit
Condition: Smoking; Smoking Cessation; Motivation; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Nicotine Patch; Nicotine Gum; Motivational Interviewing; Smoking Reduction; No Intervention; Nicotine Patch + Nicotine Gum
Intervention description: If randomized to only the Nicotine Patch condition (and not the Nicotine Gum):
Participants randomized to this condition will receive a 6-week supply of 14 mg patches at the initial visit. Participant will be instructed to use one patch daily for 6 weeks.; If randomized to only the Nicotine Gum condition (and not the Nicotine Patch):
Participants randomized to this condition will receive a 6-week supply of 2 mg gum at the initial visit. Participants will be instructed to use 10 pieces of gum daily for 6 weeks.; Participants randomized to this condition will receive an initial MI counseling session during the in-person clinic visit followed by three counseling phone calls over the 6-week intervention period (a total of four intervention contacts). The phone counseling sessions will occur during weeks 2, 4, and 6. Case managers will engage the participant in a series of motivation building exercises such as reviewing feelings and thoughts about the pros and cons of quitting and smoking, reinforcing the positives of quitting, helping to dispel myths and concerns about the negatives of quitting, and posing questions about the "good" aspects of smoking.; Participants randomized to Smoking Reduction will receive an initial counseling session during the in-person visit followed by 6 weekly phone counseling sessions over the 6-week intervention period. During the initial session, participants will be told that the goal is to reduce cigarette consumption by 50% over the course of the intervention (approximately 10% reduction per week). During the initial meeting and subsequent counseling calls, case managers will work with participants to problem-solve strategies for reduction (e.g., increasing time between cigarettes, delaying smoking, or eliminating smoking in specific situations). Participants will be asked to record information in a provided smoking log to help keep track of daily smoking patterns and as a feedback mechanism for identifying successes and challenges.; No Intervention; If randomized to both the Nicotine Patch and the Nicotine Gum conditions:
Participants randomized to this condition will receive a 6-week supply of 14 mg patches and a 6-week supply of 2 mg gum at the initial visit. Participant will be instructed to use one patch daily and to use 10 pieces of gum daily for 6 weeks.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 517.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Smoking; Smoking Cessation; Motivation; Nicotine Dependence

Summary:

      At any given point in time, most smokers are not interested in making a serious quit attempt.
      Data suggest that 30% of smokers have no plans to quit, 30% plan to quit at some future date,
      30% plan to quit in the next 6 months, and about 10% plan to quit in the next month. While
      ~40% of smokers make a quit attempt each year, only about 4-6% of those achieve long-term
      success. This means that of the more than 60 million Americans who smoke, only 1 million are
      able to quit each year. If we could double the number of quit attempts and maintain
      comparable success rates, we could double the number of individuals who will benefit from
      living smoke free lives. These observations underscore the need to develop interventions that
      increase smokers' motivation or willingness to make quit attempts, and that also increase the
      rate of success among those who attempt to quit. The overall goal of this proposed experiment
      is to identify effective interventions aimed at increasing motivation for smoking cessation,
      increasing quit attempts, and increasing rates of cessation success. Interventions that will
      be tested include: use of nicotine gum, use of nicotine patches, motivational interviewing,
      and smoking reduction counseling. At minimum, all participants will complete surveys about
      their smoking behavior that might increase their motivation to eventually quitting smoking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older;

          -  Report smoking at least 5 cigarettes per day for the previous 6 months;

          -  Able to read and write English;

          -  Available to take one phone call per week;

          -  Not currently interested in quitting smoking (defined as would not like to try to quit
             in the next 30 days),

          -  Plans to remain in the intervention catchment area for at least 12 months

          -  All women of childbearing potential will be required to agree to use an acceptable
             method of birth control to prevent pregnancy during the study.

        Exclusion Criteria:

          -  Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is
             not exclusionary if the participant agrees to use only study medication for the
             duration of the study);

          -  Study candidate is a pregnant, trying to get pregnant, or nursing;

          -  A history of psychosis or bipolar disorder

          -  A history of skin or allergic reactions while using a nicotine patch.

          -  Study candidate reports having a heart attack, stroke, or abnormal electrocardiogram
             within the past 4 weeks.