An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Transdermal nicotine patch
Intervention description: Transdermal nicotine, 21mg/day
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 525.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nicotine replacement therapy, smoking cessation, transdermal nicotine

Summary:

      The transdermal nicotine patch is the most widely used form of tobacco dependence treatment
      in the US and Europe, but most smokers are unable to successfully quit with this form of
      treatment. Failure to respond to this treatment may, to a large extent, be due to the use of
      nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a
      controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase
      quit rates significantly. We propose here a clinical trial to replicate and extend these
      results to a community setting in the real-world, using the same research design utilized in
      clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate
      dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks),
      extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The
      main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness,
      safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for
      maintenance therapy with transdermal nicotine will also be assessed. The study results may
      change how we treat nicotine dependence with transdermal nicotine.
    

Eligibility criteria:

        Inclusion Criteria: Participants will be: 1) males and females over age 18 who smoke at
        least 10 cigarettes/day; 2) able to communicate in English; 3) able to use NRT safely
        (e.g., no allergy to latex, no serious abnormal ECG reading); 4) able to provide written
        informed consent for study procedures; and 5) residing in the geographic area for at least
        12 months.

        Exclusion Criteria: Participants will be ineligible for the trial if they: 1) are unable to
        communicate in English; 2) Have a current diagnosis of psychosis and/or manic depression;
        3) have a current medical condition that would make using transdermal nicotine patch unsafe
        (e.g., allergy to latex, serious, abnormal ECG reading)- participants with asthma,
        diabetes, hypertension, or heart disease (e.g., coronary artery disease, abnormal heart
        rhythm, an arrhythmia) will be permitted to enroll in the study with medical clearance from
        the participant's physician or the study physician; 4) have had a heart attack within the
        past 6 months, 5) are pregnant or planning to become pregnant or lactating, or 6) are
        currently enrolled or plan to enroll in another research or smoking cessation program
        within the next 12 months.