Telephone Counseling and the Distribution of Nicotine Patches to Smokers
Condition: Smoking Cessation
Intervention: Nicotine Patch; Telephone Counseling; Placebo; Self-Help Materials
Intervention description: Subjects are randomized into 1 of 3 conditions: active, placebo or usual care. Usual care subjects are not mailed patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. For those mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.; Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.
Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling.; Placebo nicotine patch; Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.
Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day.
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nicotine Replacement Therapy; Nicotine Patch; Smoking cessation; Telephone; Tobacco cessation; Counseling; Nicotine; Self-Help; Smoking abstinence; Tobacco Use Disorder

Summary:

      The primary purpose of this study is to determine the effects of distributing free nicotine
      replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims
      to:

        1. Test if sending active nicotine patches directly will lead to a higher quit rate,
           compared to a condition where the quitline assists the smokers to obtain patches by
           other means (e.g. via their health plans).

        2. Test if sending placebo patches directly will also lead to a higher quit rate.

        3. Test if quitline counseling increases the quit rate when the smokers already receive the
           nicotine patches.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >= 18 years old

          -  Daily smoker

          -  >=6 cigarettes per day

          -  Ready to quit within one month

          -  First time quitline caller

          -  Valid phone number

          -  Valid address (no P.O. boxes)

          -  California resident

          -  Agree to participate in study and evaluation

          -  English or Spanish speaking

        Exclusion Criteria:

          -  Uses other form of tobacco

          -  Use of Zyban or Chantix

          -  One of the following conditions: Severe allergy to adhesive tape, Arrhythmia, Angina,
             Heart attack within last year, Stroke within last year, Uncontrolled high blood
             pressure, Insulin-dependent diabetes, Pregnancy