Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging
Condition: Smoking Cessation
Intervention: Telephone Counseling; Nicotine Patches
Intervention description: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.; Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start using it right away, or usual care patches in which no patches are sent directly (although clients may still get them through their usual channels).
For those in the usual care condition, patches will not be mailed directly to them; however, we will facilitate their use by providing a certificate that can be used by the State Medicaid program and some other insurance companies to obtain free patches. For those in the active condition, we will mail 2 weeks of patches directly to their home. All subjects will receive a 2 week starter kit with fourteen 21mg patches.
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tobacco cessation; smoking cessation; nicotine; counseling; telephone; self-help; smoking abstinence; tobacco use disorder; nicotine replacement therapy

Summary:

      The primary purpose of this study is to test the feasibility of sending pre-cessation
      nicotine patches and to examine the effects associated with the pre-cessation treatment
      phase. Specifically, this study aims to:

        1. See if subjects will use pre-cessation nicotine patches.

        2. See if subjects in the pre-cessation nicotine patches go on to get more nicotine
           patches.

        3. See if pre-cessation treatment with nicotine patches leads to a decrease in number of
           cigarettes smoked per day.

        4. See if sending 2-weeks' worth of patches is helpful to the quitting process.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >= 18 years old

          -  Daily smoker

          -  >=10 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 speaking

        Exclusion Criteria:

          -  Uses other form of tobacco

          -  Plan to use quitting aids other than nicotine patch

          -  Has any of the following conditions:

          -  Severe allergy to adhesive tape

          -  Arrhythmia

          -  Angina

          -  Heart attack within last 6 months

          -  Stroke within last 6 months

          -  Uncontrolled high blood pressure

          -  Insulin-dependent diabetes

          -  Pregnancy