Providing Free Nicotine Patches to Quitline Smokers
Condition: Smoking Cessation
Intervention: Telephone counseling; Voucher; Nicotine patches
Intervention description: Telephone counseling is conducted in the appropriate language (English and Spanish) by veteran counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling; Subjects will receive a voucher for nicotine patches.
Subjects randomized into the voucher condition will receive a voucher that can be exchanged for two weeks' worth of free starter kit nicotine patches by calling a dedicated phone number (Quit Boost). The voucher will be mailed the day after the screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.; Subjects will receive nicotine patches directly sent to their home. Subjects randomized into the patch condition will receive two weeks' worth of free starter kit nicotine patches directly. The patches will be mailed directly to their home the day after screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3706.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tobacco cessation; smoking cessation; nicotine; telephone counseling; self-help; smoking abstinence; tobacco use disorder; nicotine replacement therapy; voucher

Summary:

      The California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling
      condition) randomized trial to test the provision of nicotine patches to help smokers calling
      a telephone quitline. The study assesses one factor related to nicotine patches with 3
      levels: sending patches directly from the Helpline, providing vouchers that can be redeemed
      for patches, and usual care. A second factor is counseling plus materials versus materials
      only. This proposed study has the following specific aims:

        1. To demonstrate that a voucher for free nicotine patches will increase the quit rate for
           smokers who do not have access to free nicotine replacement therapy (NRT)

        2. To demonstrate that sending patches directly from a quitline would outperform sending
           vouchers for free NRT, since the vouchers impose an additional barrier to those who want
           to quit

        3. To determine the effect of telephone counseling in the context of nicotine patch
           distribution and if any interaction effects exist between counseling and patch
           conditions
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Current smoker

          -  First time quitline caller

          -  Not eligible for nicotine patches through other programs such as MediCal or Los
             Angeles County which provides free nicotine patches

          -  English and/or Spanish speaking

          -  Valid phone number

          -  Valid address

          -  CA resident

          -  Gave consent to participate in study and evaluation

        Exclusion Criteria:

          -  Contraindication(s) to nicotine patches

          -  Uses a form of tobacco other than cigarettes

          -  Plans to use Chantix